Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases

<!DOCTYPE html> <html lang="en-US"> <head> <meta charset="UTF-8" /> <meta http-equiv="X-UA-Compatible" content="IE=edge"> <meta name="viewport" content="width=device-width, initial-scale=1" /> <link data-minify="1" rel="stylesheet" href="https://www.ipsen.com/wp-content/cache/min/0/npm/bootstrap-icons@1.9.1/font/bootstrap-icons.css?ver=1732278433">  <script async src="https://www.googletagmanager.com/gtag/js?id=AW-16501157862"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'AW-16501157862'); </script>  <script type="text/javascript"> _linkedin_partner_id = "5855114"; window._linkedin_data_partner_ids = window._linkedin_data_partner_ids || []; window._linkedin_data_partner_ids.push(_linkedin_partner_id); </script> <script type="text/javascript"> (function(l) { if (!l){window.lintrk = function(a,b){window.lintrk.q.push([a,b])}; window.lintrk.q=[]} var s = document.getElementsByTagName("script")[0]; var b = document.createElement("script"); b.type = "text/javascript";b.async = true; b.src = https://snap.licdn.com/li.lms-analytics/insight.min.js; s.parentNode.insertBefore(b, s);})(window.lintrk); </script> <noscript> <img height="1" width="1" style="display:none;" alt="" src=https://px.ads.linkedin.com/collect/?pid=5855114&fmt=gif /> </noscript> <meta name='robots' content='index, follow, max-image-preview:large, max-snippet:-1, max-video-preview:-1' /> <link rel="alternate" hreflang="en" href="https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/" /> <link rel="alternate" hreflang="fr" href="https://www.ipsen.com/fr/press-releases/ipsen-recoit-des-avis-positifs-du-chmp-pour-iqirvo-elafibranor-dans-la-cholangite-biliaire-primitive-et-kayfanda-odevixibat-dans-le-syndrome-dalagille-deux-maladies-rares-du-foie-cho-2919457/" /> <link rel="alternate" hreflang="x-default" href="https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/" />  <title>Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases</title> <link rel="preload" as="font" href="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/fonts/Lato-Bold.ttf" crossorigin> <link rel="preload" as="font" href="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/fonts/Lato-Light.ttf" crossorigin> <link rel="preload" as="font" href="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/fonts/Lato-Regular.ttf" crossorigin> <link rel="preload" as="font" href="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/fonts/Lato-Semibold.ttf" crossorigin> <link rel="canonical" href="https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/" /> <meta property="og:locale" content="en_US" /> <meta property="og:type" content="article" /> <meta property="og:title" content="Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases" /> <meta property="og:url" content="https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/" /> <meta property="og:site_name" content="Global" /> <meta property="article:modified_time" content="2024-07-26T10:51:36+00:00" /> <meta property="og:image" content="https://ml-eu.globenewswire.com/media/ZGUwMWU1NmQtYWE3NC00YzQ0LTk1NDItM2UxZjg2NjE2MzU0LTEyNjgxMTY=/tiny/Ipsen-Pharma.png" /> <meta name="twitter:card" content="summary_large_image" /> <meta name="twitter:site" content="@ipsengroup" /> <meta name="twitter:label1" content="Est. reading time" /> <meta name="twitter:data1" content="16 minutes" /> <script type="application/ld+json" class="yoast-schema-graph">{"@context":"https://schema.org","@graph":[{"@type":"NewsArticle","@id":"https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/#article","isPartOf":{"@id":"https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/"},"author":{"name":"IPSEN","@id":"https://www.ipsen.com/#/schema/person/81bf851fdec8a6fd535e94f631c502b0"},"headline":"Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases","datePublished":"2024-07-26T10:46:27+00:00","dateModified":"2024-07-26T10:51:36+00:00","mainEntityOfPage":{"@id":"https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/"},"wordCount":3125,"publisher":{"@id":"https://www.ipsen.com/#organization"},"image":{"@id":"https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/#primaryimage"},"thumbnailUrl":"https://ml-eu.globenewswire.com/media/ZGUwMWU1NmQtYWE3NC00YzQ0LTk1NDItM2UxZjg2NjE2MzU0LTEyNjgxMTY=/tiny/Ipsen-Pharma.png","articleSection":["Corporate","Rare Diseases"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/","url":"https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/","name":"Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases","isPartOf":{"@id":"https://www.ipsen.com/#website"},"primaryImageOfPage":{"@id":"https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/#primaryimage"},"image":{"@id":"https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/#primaryimage"},"thumbnailUrl":"https://ml-eu.globenewswire.com/media/ZGUwMWU1NmQtYWE3NC00YzQ0LTk1NDItM2UxZjg2NjE2MzU0LTEyNjgxMTY=/tiny/Ipsen-Pharma.png","datePublished":"2024-07-26T10:46:27+00:00","dateModified":"2024-07-26T10:51:36+00:00","breadcrumb":{"@id":"https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/#primaryimage","url":"https://ml-eu.globenewswire.com/media/ZGUwMWU1NmQtYWE3NC00YzQ0LTk1NDItM2UxZjg2NjE2MzU0LTEyNjgxMTY=/tiny/Ipsen-Pharma.png","contentUrl":"https://ml-eu.globenewswire.com/media/ZGUwMWU1NmQtYWE3NC00YzQ0LTk1NDItM2UxZjg2NjE2MzU0LTEyNjgxMTY=/tiny/Ipsen-Pharma.png"},{"@type":"BreadcrumbList","@id":"https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.ipsen.com/"},{"@type":"ListItem","position":2,"name":"Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases"}]},{"@type":"WebSite","@id":"https://www.ipsen.com/#website","url":"https://www.ipsen.com/","name":"Global","description":"","publisher":{"@id":"https://www.ipsen.com/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https://www.ipsen.com/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https://www.ipsen.com/#organization","name":"IPSEN","url":"https://www.ipsen.com/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https://www.ipsen.com/#/schema/logo/image/","url":"https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/12/07162335/Latest_Ipsen-logo_168x48.svg","contentUrl":"https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/12/07162335/Latest_Ipsen-logo_168x48.svg","caption":"IPSEN"},"image":{"@id":"https://www.ipsen.com/#/schema/logo/image/"},"sameAs":["https://www.facebook.com/Ipsengroup","https://x.com/ipsengroup"]},{"@type":"Person","@id":"https://www.ipsen.com/#/schema/person/81bf851fdec8a6fd535e94f631c502b0","name":"IPSEN","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https://www.ipsen.com/#/schema/person/image/","url":"https://secure.gravatar.com/avatar/9567f50289ed3f8d4c65927e8de9f6fc?s=96&d=mm&r=g","contentUrl":"https://secure.gravatar.com/avatar/9567f50289ed3f8d4c65927e8de9f6fc?s=96&d=mm&r=g","caption":"IPSEN"},"sameAs":["https://www.ipsen.com"]}]}</script>  <link rel='dns-prefetch' href='//maps.google.com' /> <style id='wp-emoji-styles-inline-css'> img.wp-smiley, img.emoji { display: inline !important; border: none !important; box-shadow: none !important; height: 1em !important; width: 1em !important; margin: 0 0.07em !important; vertical-align: -0.1em !important; background: none !important; padding: 0 !important; } </style> <link rel='stylesheet' id='wp-block-library-css' href='https://www.ipsen.com/wp-includes/css/dist/block-library/style.min.css?ver=6.6.2' media='all' /> <style id='wp-block-library-theme-inline-css'> .wp-block-audio :where(figcaption){color:#555;font-size:13px;text-align:center}.is-dark-theme .wp-block-audio :where(figcaption){color:#ffffffa6}.wp-block-audio{margin:0 0 1em}.wp-block-code{border:1px solid #ccc;border-radius:4px;font-family:Menlo,Consolas,monaco,monospace;padding:.8em 1em}.wp-block-embed :where(figcaption){color:#555;font-size:13px;text-align:center}.is-dark-theme .wp-block-embed :where(figcaption){color:#ffffffa6}.wp-block-embed{margin:0 0 1em}.blocks-gallery-caption{color:#555;font-size:13px;text-align:center}.is-dark-theme .blocks-gallery-caption{color:#ffffffa6}:root :where(.wp-block-image figcaption){color:#555;font-size:13px;text-align:center}.is-dark-theme :root :where(.wp-block-image figcaption){color:#ffffffa6}.wp-block-image{margin:0 0 1em}.wp-block-pullquote{border-bottom:4px solid;border-top:4px solid;color:currentColor;margin-bottom:1.75em}.wp-block-pullquote cite,.wp-block-pullquote footer,.wp-block-pullquote__citation{color:currentColor;font-size:.8125em;font-style:normal;text-transform:uppercase}.wp-block-quote{border-left:.25em solid;margin:0 0 1.75em;padding-left:1em}.wp-block-quote cite,.wp-block-quote footer{color:currentColor;font-size:.8125em;font-style:normal;position:relative}.wp-block-quote.has-text-align-right{border-left:none;border-right:.25em solid;padding-left:0;padding-right:1em}.wp-block-quote.has-text-align-center{border:none;padding-left:0}.wp-block-quote.is-large,.wp-block-quote.is-style-large,.wp-block-quote.is-style-plain{border:none}.wp-block-search .wp-block-search__label{font-weight:700}.wp-block-search__button{border:1px solid #ccc;padding:.375em .625em}:where(.wp-block-group.has-background){padding:1.25em 2.375em}.wp-block-separator.has-css-opacity{opacity:.4}.wp-block-separator{border:none;border-bottom:2px solid;margin-left:auto;margin-right:auto}.wp-block-separator.has-alpha-channel-opacity{opacity:1}.wp-block-separator:not(.is-style-wide):not(.is-style-dots){width:100px}.wp-block-separator.has-background:not(.is-style-dots){border-bottom:none;height:1px}.wp-block-separator.has-background:not(.is-style-wide):not(.is-style-dots){height:2px}.wp-block-table{margin:0 0 1em}.wp-block-table td,.wp-block-table th{word-break:normal}.wp-block-table :where(figcaption){color:#555;font-size:13px;text-align:center}.is-dark-theme .wp-block-table :where(figcaption){color:#ffffffa6}.wp-block-video :where(figcaption){color:#555;font-size:13px;text-align:center}.is-dark-theme .wp-block-video :where(figcaption){color:#ffffffa6}.wp-block-video{margin:0 0 1em}:root :where(.wp-block-template-part.has-background){margin-bottom:0;margin-top:0;padding:1.25em 2.375em} </style> <style id='classic-theme-styles-inline-css'> /*! This file is auto-generated */ .wp-block-button__link{color:#fff;background-color:#32373c;border-radius:9999px;box-shadow:none;text-decoration:none;padding:calc(.667em + 2px) calc(1.333em + 2px);font-size:1.125em}.wp-block-file__button{background:#32373c;color:#fff;text-decoration:none} </style> <style id='global-styles-inline-css'> :root{--wp--preset--aspect-ratio--square: 1;--wp--preset--aspect-ratio--4-3: 4/3;--wp--preset--aspect-ratio--3-4: 3/4;--wp--preset--aspect-ratio--3-2: 3/2;--wp--preset--aspect-ratio--2-3: 2/3;--wp--preset--aspect-ratio--16-9: 16/9;--wp--preset--aspect-ratio--9-16: 9/16;--wp--preset--color--black: #000000;--wp--preset--color--cyan-bluish-gray: #abb8c3;--wp--preset--color--white: #ffffff;--wp--preset--color--pale-pink: #f78da7;--wp--preset--color--vivid-red: #cf2e2e;--wp--preset--color--luminous-vivid-orange: #ff6900;--wp--preset--color--luminous-vivid-amber: #fcb900;--wp--preset--color--light-green-cyan: #7bdcb5;--wp--preset--color--vivid-green-cyan: #00d084;--wp--preset--color--pale-cyan-blue: #8ed1fc;--wp--preset--color--vivid-cyan-blue: #0693e3;--wp--preset--color--vivid-purple: #9b51e0;--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple: linear-gradient(135deg,rgba(6,147,227,1) 0%,rgb(155,81,224) 100%);--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan: linear-gradient(135deg,rgb(122,220,180) 0%,rgb(0,208,130) 100%);--wp--preset--gradient--luminous-vivid-amber-to-luminous-vivid-orange: linear-gradient(135deg,rgba(252,185,0,1) 0%,rgba(255,105,0,1) 100%);--wp--preset--gradient--luminous-vivid-orange-to-vivid-red: linear-gradient(135deg,rgba(255,105,0,1) 0%,rgb(207,46,46) 100%);--wp--preset--gradient--very-light-gray-to-cyan-bluish-gray: linear-gradient(135deg,rgb(238,238,238) 0%,rgb(169,184,195) 100%);--wp--preset--gradient--cool-to-warm-spectrum: linear-gradient(135deg,rgb(74,234,220) 0%,rgb(151,120,209) 20%,rgb(207,42,186) 40%,rgb(238,44,130) 60%,rgb(251,105,98) 80%,rgb(254,248,76) 100%);--wp--preset--gradient--blush-light-purple: linear-gradient(135deg,rgb(255,206,236) 0%,rgb(152,150,240) 100%);--wp--preset--gradient--blush-bordeaux: linear-gradient(135deg,rgb(254,205,165) 0%,rgb(254,45,45) 50%,rgb(107,0,62) 100%);--wp--preset--gradient--luminous-dusk: linear-gradient(135deg,rgb(255,203,112) 0%,rgb(199,81,192) 50%,rgb(65,88,208) 100%);--wp--preset--gradient--pale-ocean: linear-gradient(135deg,rgb(255,245,203) 0%,rgb(182,227,212) 50%,rgb(51,167,181) 100%);--wp--preset--gradient--electric-grass: linear-gradient(135deg,rgb(202,248,128) 0%,rgb(113,206,126) 100%);--wp--preset--gradient--midnight: linear-gradient(135deg,rgb(2,3,129) 0%,rgb(40,116,252) 100%);--wp--preset--font-size--small: 13px;--wp--preset--font-size--medium: 20px;--wp--preset--font-size--large: 36px;--wp--preset--font-size--x-large: 42px;--wp--preset--spacing--20: 0.44rem;--wp--preset--spacing--30: 0.67rem;--wp--preset--spacing--40: 1rem;--wp--preset--spacing--50: 1.5rem;--wp--preset--spacing--60: 2.25rem;--wp--preset--spacing--70: 3.38rem;--wp--preset--spacing--80: 5.06rem;--wp--preset--shadow--natural: 6px 6px 9px rgba(0, 0, 0, 0.2);--wp--preset--shadow--deep: 12px 12px 50px rgba(0, 0, 0, 0.4);--wp--preset--shadow--sharp: 6px 6px 0px rgba(0, 0, 0, 0.2);--wp--preset--shadow--outlined: 6px 6px 0px -3px rgba(255, 255, 255, 1), 6px 6px rgba(0, 0, 0, 1);--wp--preset--shadow--crisp: 6px 6px 0px rgba(0, 0, 0, 1);}:where(.is-layout-flex){gap: 0.5em;}:where(.is-layout-grid){gap: 0.5em;}body .is-layout-flex{display: flex;}.is-layout-flex{flex-wrap: wrap;align-items: center;}.is-layout-flex > :is(*, div){margin: 0;}body .is-layout-grid{display: grid;}.is-layout-grid > :is(*, div){margin: 0;}:where(.wp-block-columns.is-layout-flex){gap: 2em;}:where(.wp-block-columns.is-layout-grid){gap: 2em;}:where(.wp-block-post-template.is-layout-flex){gap: 1.25em;}:where(.wp-block-post-template.is-layout-grid){gap: 1.25em;}.has-black-color{color: var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-color{color: var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-color{color: var(--wp--preset--color--white) !important;}.has-pale-pink-color{color: var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-color{color: var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-color{color: var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-color{color: var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-color{color: var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-color{color: var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-color{color: var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-color{color: var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-color{color: var(--wp--preset--color--vivid-purple) !important;}.has-black-background-color{background-color: var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-background-color{background-color: var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-background-color{background-color: var(--wp--preset--color--white) !important;}.has-pale-pink-background-color{background-color: var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-background-color{background-color: var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-background-color{background-color: var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-background-color{background-color: var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-background-color{background-color: var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-background-color{background-color: var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-background-color{background-color: var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-background-color{background-color: var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-background-color{background-color: var(--wp--preset--color--vivid-purple) !important;}.has-black-border-color{border-color: var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-border-color{border-color: var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-border-color{border-color: var(--wp--preset--color--white) !important;}.has-pale-pink-border-color{border-color: var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-border-color{border-color: var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-border-color{border-color: var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-border-color{border-color: var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-border-color{border-color: var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-border-color{border-color: var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-border-color{border-color: var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-border-color{border-color: var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-border-color{border-color: var(--wp--preset--color--vivid-purple) !important;}.has-vivid-cyan-blue-to-vivid-purple-gradient-background{background: var(--wp--preset--gradient--vivid-cyan-blue-to-vivid-purple) !important;}.has-light-green-cyan-to-vivid-green-cyan-gradient-background{background: var(--wp--preset--gradient--light-green-cyan-to-vivid-green-cyan) !important;}.has-luminous-vivid-amber-to-luminous-vivid-orange-gradient-background{background: var(--wp--preset--gradient--luminous-vivid-amber-to-luminous-vivid-orange) !important;}.has-luminous-vivid-orange-to-vivid-red-gradient-background{background: var(--wp--preset--gradient--luminous-vivid-orange-to-vivid-red) !important;}.has-very-light-gray-to-cyan-bluish-gray-gradient-background{background: var(--wp--preset--gradient--very-light-gray-to-cyan-bluish-gray) !important;}.has-cool-to-warm-spectrum-gradient-background{background: var(--wp--preset--gradient--cool-to-warm-spectrum) !important;}.has-blush-light-purple-gradient-background{background: var(--wp--preset--gradient--blush-light-purple) !important;}.has-blush-bordeaux-gradient-background{background: var(--wp--preset--gradient--blush-bordeaux) !important;}.has-luminous-dusk-gradient-background{background: var(--wp--preset--gradient--luminous-dusk) !important;}.has-pale-ocean-gradient-background{background: var(--wp--preset--gradient--pale-ocean) !important;}.has-electric-grass-gradient-background{background: var(--wp--preset--gradient--electric-grass) !important;}.has-midnight-gradient-background{background: var(--wp--preset--gradient--midnight) !important;}.has-small-font-size{font-size: var(--wp--preset--font-size--small) !important;}.has-medium-font-size{font-size: var(--wp--preset--font-size--medium) !important;}.has-large-font-size{font-size: var(--wp--preset--font-size--large) !important;}.has-x-large-font-size{font-size: var(--wp--preset--font-size--x-large) !important;} :where(.wp-block-post-template.is-layout-flex){gap: 1.25em;}:where(.wp-block-post-template.is-layout-grid){gap: 1.25em;} :where(.wp-block-columns.is-layout-flex){gap: 2em;}:where(.wp-block-columns.is-layout-grid){gap: 2em;} :root :where(.wp-block-pullquote){font-size: 1.5em;line-height: 1.6;} </style> <link data-minify="1" rel='stylesheet' id='wpml-blocks-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/plugins/sitepress-multilingual-cms/dist/css/blocks/styles.css?ver=1732278433' media='all' /> <link data-minify="1" rel='stylesheet' id='wpgmp-frontend-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/plugins/wp-google-map-gold/assets/css/frontend.min.css?ver=1732278433' media='all' /> <link rel='stylesheet' id='bootstrap-min-css' href='https://www.ipsen.com/wp-content/themes/ipsen-main/dist/css/bootstrap.min.css?ver=1732416125' media='all' /> <link rel='stylesheet' id='caraousal-glider-min-css' href='https://www.ipsen.com/wp-content/themes/ipsen-main/dist/css/glider.min.css?ver=1732416125' media='all' /> <link data-minify="1" rel='stylesheet' id='slick-theme-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/dist/css/slick-theme.css?ver=1732278433' media='all' /> <link data-minify="1" rel='stylesheet' id='slick-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/dist/css/slick.css?ver=1732278433' media='all' /> <link data-minify="1" rel='stylesheet' id='media-filter-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/dist/css/media-filter.css?ver=1732278433' media='all' /> <link data-minify="1" rel='stylesheet' id='ipsen-gravity-form-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/dist/css/gravity-form-style.css?ver=1732278433' media='all' /> <link data-minify="1" rel='stylesheet' id='single-post-css-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/dist/css/single-post.css?ver=1732278436' media='all' /> <link data-minify="1" rel='stylesheet' id='related-story-css-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/dist/css/related-story.css?ver=1732278436' media='all' /> <link data-minify="1" rel='stylesheet' id='page-banner-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/template-parts/ipsen-blocks/page-banner/page-banner-block.css?ver=1732278433' media='all' /> <link data-minify="1" rel='stylesheet' id='global-css-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/dist/css/global.css?ver=1732278433' media='all' /> <link data-minify="1" rel='stylesheet' id='ipsenmain-style-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/style.css?ver=1732278433' media='all' /> <link data-minify="1" rel='stylesheet' id='book-meeting-css' href='https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/template-parts/ipsen-blocks/book-meeting/css/book-meeting.css?ver=1732278433' media='all' /> <script id="wpml-cookie-js-extra"> var wpml_cookies = {"wp-wpml_current_language":{"value":"en","expires":1,"path":"\/"}}; var wpml_cookies = {"wp-wpml_current_language":{"value":"en","expires":1,"path":"\/"}}; </script> <script data-minify="1" src="https://www.ipsen.com/wp-content/cache/min/0/wp-content/plugins/sitepress-multilingual-cms/res/js/cookies/language-cookie.js?ver=1732278433" id="wpml-cookie-js" defer data-wp-strategy="defer"></script> <script src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/js/jquery.min.js?ver=1732416125" id="jquery-min-theme-js"></script> <script src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/js/bootstrap.min.js?ver=1732416125" id="bootstrap-min-js"></script> <script src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/js/popper.min.js?ver=1732416125" id="popper-min-js"></script> <script src="https://www.ipsen.com/wp-includes/js/jquery/jquery.min.js?ver=3.7.1" id="jquery-core-js"></script> <script src="https://www.ipsen.com/wp-includes/js/jquery/jquery-migrate.min.js?ver=3.4.1" id="jquery-migrate-js"></script> <script data-minify="1" src="https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/dist/js/jquery.overflowing.js?ver=1732278433" id="jquery-overflowing-js"></script> <link rel="https://api.w.org/" href="https://www.ipsen.com/wp-json/" /><link rel="alternate" title="JSON" type="application/json" href="https://www.ipsen.com/wp-json/wp/v2/press_release/62834" /><link rel="EditURI" type="application/rsd+xml" title="RSD" href="https://www.ipsen.com/xmlrpc.php?rsd" /> <meta name="generator" content="WordPress 6.6.2" /> <link rel='shortlink' href='https://www.ipsen.com/?p=62834' /> <link rel="alternate" title="oEmbed (JSON)" type="application/json+oembed" href="https://www.ipsen.com/wp-json/oembed/1.0/embed?url=https%3A%2F%2Fwww.ipsen.com%2Fpress-releases%2Fipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457%2F" /> <link rel="alternate" title="oEmbed (XML)" type="text/xml+oembed" href="https://www.ipsen.com/wp-json/oembed/1.0/embed?url=https%3A%2F%2Fwww.ipsen.com%2Fpress-releases%2Fipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457%2F&format=xml" /> <meta name="generator" content="WPML ver:4.6.9 stt:1,4;" /> <input type="hidden" id="ipn-all-sites" value="["us","annualreport","mx","aus","germany","be","netherlands","it","greece","japan","austria","switzerland","cn","france","canada","es","middleeast","uk"]"><link rel="icon" href="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19135239/favicon.png" sizes="32x32" /> <link rel="icon" href="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19135239/favicon.png" sizes="192x192" /> <link rel="apple-touch-icon" href="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19135239/favicon.png" /> <meta name="msapplication-TileImage" content="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19135239/favicon.png" /> <noscript><style id="rocket-lazyload-nojs-css">.rll-youtube-player, [data-lazy-src]{display:none !important;}</style></noscript>  <script data-minify="1" type="text/javascript" src="https://www.ipsen.com/wp-content/cache/min/0/consent/d11c622a-1c38-4917-b40c-dbf9215c59e9/OtAutoBlock.js?ver=1732278433" ></script> <script src=https://cdn.cookielaw.org/scripttemplates/otSDKStub.js type="text/javascript" charset="UTF-8" data-domain-script="d11c622a-1c38-4917-b40c-dbf9215c59e9" ></script> <script type="text/javascript"> function OptanonWrapper() { } </script>  </head> <body class="press_release-template-default single single-press_release postid-62834 wp-custom-logo no-js singular has-main-navigation"> <script> (function(window,document,dataLayerName,id){ window[dataLayerName]=window[dataLayerName]||[],window[dataLayerName].push({start:(new Date).getTime(),event:"stg.start"});var scripts=document.getElementsByTagName('script')[0],tags=document.createElement('script'); function stgCreateCookie(a,b,c){var d="";if(c){var e=new Date;e.setTime(e.getTime()+24*c*60*60*1e3),d=";expires="+e.toUTCString()}document.cookie=a+"="+b+d+";path=/"} var isStgDebug=(window.location.href.match("stg_debug")||document.cookie.match("stg_debug"))&&!window.location.href.match("stg_disable_debug");stgCreateCookie("stg_debug",isStgDebug?1:"",isStgDebug?14:-1); var qP=[];dataLayerName!=="dataLayer"&&qP.push("data_layer_name="+dataLayerName),isStgDebug&&qP.push("stg_debug");var qPString=qP.length>0?("?"+qP.join("&")):""; tags.async=!0,tags.src="https://myipsen.containers.piwik.pro/"+id+".js"+qPString,scripts.parentNode.insertBefore(tags,scripts); !function(a,n,i){a[n]=a[n]||{};for(var c=0;c<i.length;c++)!function(i){a[n][i]=a[n][i]||{},a[n][i].api=a[n][i].api||function(){var a=[].slice.call(arguments,0);"string"==typeof a[0]&&window[dataLayerName].push({event:n+"."+i+":"+a[0],parameters:[].slice.call(arguments,1)})}}(i[c])}(window,"ppms",["tm","cm"]); })(window,document,'dataLayer','bc936ea2-3363-4e59-ae1d-225c5bacf308'); </script> <div class="container-fluid siteId-1">  <section class="masthead sticky-top" id="masthead"> <div class="container"> <div class="row"> <nav class="navbar navbar-expand-lg navbar-light"> <div class="col-lg-4 col-md-12 col-sm-12 mobHeadView"> <a class="navbar-brand" href="https://www.ipsen.com/" aria-label="Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases"> <span class="custom-logo-link"> <img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/12/07162335/Latest_Ipsen-logo_168x48.svg" class="custom-logo" alt="Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases" decoding="async"> </span> </a> <a class="nav-link mobile-view searchDropdown" aria-current="page" id="searchDropdownLnk" href="#" aria-label="Search" aria-labelledby="searchDropdown" role="button" title="Search" data-bs-toggle="dropdown" data-bs-auto-close="outside" aria-expanded="false"></a> <div class="dropdown-menu searchBar dropdown-menu-end" aria-labelledby="searchDropdown" id="searchDropdownMobile" data-bs-auto-close="false"> <div class="row"> <div class="col-sm-3 col-md-3"> <select class="form-select shadow-none" aria-label="Default-select" name="cat" id="category_list" onChange="getCategory(this.value)" > <option selected value=""> All </option> <option value="post">Stories</option> <option value="press_release">Press Releases</option> <option value="attachment">Documents</option> <option value="event">Events</option> <option value="statements">Statements</option> <option value="others">Other</option> </select> </div> <input class="form-control" type="hidden" value="1" name="currentstore" id="currentstore"/> <input class="form-control" type="hidden" value="en" name="current_language_code_piped" id="current_language_code_piped"/> <input class="form-control" type="hidden" value="Global" name="current_blog_name" id="current_blog_name"/> <div class="col-sm-9 col-md-9"> <div class="input-group" id="inputInfo"> <input class="form-control shadow-none searchInput" type="search" value="" name="s" onKeyUp="show_results(this.value)" onChange="show_results(this.value)" autofocus/> <span class="input-group-append"> <button class="btn bg-white" type="button" onClick="send_search_data(this)" > <span class="search-right-arrow"></span> </button> </span> </div> </div> </div> <hr class="hr-search-divider"> <div class="row"> <div class="lds-dual-ring overlay loader" style="display:none;"> Loading...</div> <div class="cacheList autoSuggestion"> </div> </div> </div> <button class="navbar-toggler" type="button" data-bs-toggle="collapse" data-bs-target="#navbarSupportedGlobal" aria-controls="navbarSupportedContent" aria-expanded="false" aria-label="Toggle navigation"> <span class="navbar-toggler-icon"></span> </button> </div> <div class="col-md-12 col-sm-12"> <div class="collapse navbar-collapse" id="navbarSupportedGlobal"> <ul class="nav navbar ms-auto mb-2 mb-lg-0 navbar-expand-lg globalNavigation"> <li class="nav-item dropdown"> </li> <li class="nav-item dropdown has-megamenu"> <a href="#" class="nav-link cool-link" id="megaDropdown" role="button" data-bs-toggle="dropdown" data-bs-auto-close="outside" aria-expanded="false">Media  <img src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/down.png" alt="arrow_down" title="arrow_down" ></a> <div class="dropdown-menu megamenu" aria-labelledby="megaDropdown"> <div class="row"> <div class="col-lg-6 col-md-6 col-sm-6 megamenu-left"> <div class="col-megamenu"> <div class="go-back-menu mobile-view"> < Back </div> <ul class="list-unstyled submenu" aria-labelledby="megaDropdown"> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/press-release/">Press Releases </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/media-statements/">Media Statements </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/media-library/">Media Library </a> </li> </ul> </div> </div> <div class="col-lg-6 col-md-6 col-sm-6 megamenu-right"> <div class="col-megamenu"> <ul class="list-unstyled submenu"> <li> <div class="megamenuFeature"> <a href="https://www.ipsen.com/general/our-2023-integrated-annual-report-is-live/"><p>Our 2023 Integrated Annual Report is live!</p></a> <img class="img-fluid" src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%20260%20140'%3E%3C/svg%3E" width="260px" height="140px" alt="Featured Image" title="Featured Image" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/05/17174619/TL-graphic.jpg" ><noscript><img class="img-fluid" src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/05/17174619/TL-graphic.jpg" width="260px" height="140px" alt="Featured Image" title="Featured Image" ></noscript> </div> </li> </ul> </div> </div> </div> </div> </li> <li class="nav-item dropdown"> <a href="#" class="nav-link cool-link" role="button" data-bs-toggle="dropdown" data-bs-auto-close="outside" aria-expanded="false">Investors<img src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/down.png" alt="arrow_down" title="arrow_down" ></a> <ul class="dropdown-menu submenu" aria-labelledby="navbarDropdown"> <div class="go-back-menu mobile-view"> < Back </div> <li> <a class="nav-link cool-link active mobile-view">Investors</a></li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/investors/">Investors </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/investors/financial-results/">Financial Results </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/investors/reports-and-accounts/">Annual Reports and Accounts </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/investors/corporate-news/">Corporate News </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/investors/financial-calendar/">Financial Calendar </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/investors/investor-events/">Investor Events </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/investors/shareholders-information/">Shareholder Information </a> </li> <li><a class="dropdown-item submenu-item" href="https://tools.euroland.com/investortools/f-ipn/bundle.html">Share-Price Data </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/investors/regulated-information/">Regulated Information </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/contact-us/key-contacts/">Key Contacts </a> </li> </ul> <li class="nav-item "> <a class="nav-link cool-link " aria-current="page" href="https://www.ipsen.com/partnering/" target="_self" >Partnering</a> </li> <li class="nav-item dropdown"> <a href="#" class="nav-link cool-link" role="button" data-bs-toggle="dropdown" data-bs-auto-close="outside" aria-expanded="false">Careers<img src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/down.png" alt="arrow_down" title="arrow_down" ></a> <ul class="dropdown-menu submenu" aria-labelledby="navbarDropdown"> <div class="go-back-menu mobile-view"> < Back </div> <li> <a class="nav-link cool-link active mobile-view">Careers</a></li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/careers/">Careers </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/careers/working-at-ipsen/">Working at Ipsen </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/careers/our-culture/">Culture </a> </li> </ul> </ul> <div class="vr verticle-divider"></div> <ul class="nav navbar navbar-expand-lg globalRight"> <li class="nav-item dropdown"> <a class="nav-link desktop-view searchDropdown" aria-current="page" id="searchDropdownMnu" href="#" aria-label="Search" aria-labelledby="searchDropdown" role="button" title="Search" data-bs-toggle="dropdown" data-bs-auto-close="outside" aria-expanded="false"></a> <div class="dropdown-menu searchBar dropdown-menu-end" aria-labelledby="searchDropdown" id="searchDropdownMnu" data-bs-auto-close="false"> <div class="row"> <div class="col-sm-3 col-md-3 searchDivider search-left-grid"> <select class="form-select shadow-none" aria-label="Default-select" name="cat" id="cat_list" onChange="getCategory(this.value)"> <option value="">All</option> <option value="post">Stories</option> <option value="press_release">Press Releases</option> <option value="attachment">Documents</option> <option value="event">Events</option> <option value="statements">Statements</option> <option value="others">Other</option> </select> </div> <div class="col-sm-9 col-md-9 search-right-grid"> <div class="input-group" id="inputInfo"> <input class="form-control" type="hidden" value="1" name="currentstore" id="currentstore"/> <input class="form-control" type="hidden" value="Global" name="current_blog_name" id="current_blog_name"/> <input type="hidden" value="" name="cat" id="cat" /> <input class="form-control shadow-none searchInput" type="search" value="" name="s" onKeyUp="show_results(this.value)" onChange="show_results(this.value)" autofocus style="width:80%;"/> <span class="input-group-append"> <button class="btn bg-white" type="button" onClick="send_search_data(this)"> <span class="search-right-arrow"></span> </button> </span> </div> </div> </div> <hr class="hr-search-divider"> <div class="row"> <div class="lds-dual-ring overlay loader" style="display:none;"> Loading...</div> <div class="cacheList autoSuggestion"> </div> </div> </div> </li> <li class="nav-item dropdown lang-dropdown"> <a class="nav-link active languageDropdown mobile-view" href="https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/" >English&emsp; EN</a> &emsp;&emsp;&emsp; <a class="nav-link languageDropdown mobile-view" href="https://www.ipsen.com/fr/press-releases/ipsen-recoit-des-avis-positifs-du-chmp-pour-iqirvo-elafibranor-dans-la-cholangite-biliaire-primitive-et-kayfanda-odevixibat-dans-le-syndrome-dalagille-deux-maladies-rares-du-foie-cho-2919457/" >Français&emsp; FR</a> &emsp;&emsp;&emsp; <a class="nav-link desktop-view" href="#" id="languageDropdown" role="button" data-bs-toggle="dropdown" aria-expanded="false">EN  <img src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/down.png" alt="arrow_down" title="arrow_down" ></a> <ul class="dropdown-menu langUl dropdown-menu-end" aria-labelledby="navbarDropdown"> <li><a class="dropdown-item language active" href="https://www.ipsen.com/press-releases/ipsen-receives-chmp-positive-opinions-for-iqirvo-elafibranor-in-primary-biliary-cholangitis-and-kayfanda-odevixibat-in-alagille-syndrome-two-rare-cholestatic-liver-diseases-2919457/">English<span>EN</span></a></li> <li><a class="dropdown-item language " href="https://www.ipsen.com/fr/press-releases/ipsen-recoit-des-avis-positifs-du-chmp-pour-iqirvo-elafibranor-dans-la-cholangite-biliaire-primitive-et-kayfanda-odevixibat-dans-le-syndrome-dalagille-deux-maladies-rares-du-foie-cho-2919457/">Français<span>FR</span></a></li> </ul> </li> <li class="nav-item dropdown"> <form> <a class="nav-link" href="#" id="globalDropdown" data-bs-auto-close="outside" data-bs-toggle="dropdown" aria-haspopup="true" aria-expanded="false"><img src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/Global.png" alt="Global" title="Global" > Global</a> <div class="dropdown-menu globalUl dropdown-menu-end" aria-labelledby="globalDropdown"> <div class="container globalUlContainer"> <a class="nav-link globalDropdown go-country-back mobile-view" href="#" id="globalDropdownMobile"> < Back </a> <ul class="default_cnty"> <li><a class="active" href="https://www.ipsen.com">Global</a> <a class="globalDropdown active" href="https://www.ipsen.com/"> EN</a> <a class="globalDropdown " href="https://www.ipsen.com/fr"> FR</a> </li> <li><a href="https://www.ipsen.com/annualreport" class="">Annual Report</a> <a href="https://www.ipsen.com/annualreport" class="globalDropdown ">EN</a> <a href="https://www.ipsen.com/annualreport/fr" class="globalDropdown ">FR</a> </li> </ul> <ul class="nav nav-tabs globalTab" id="globalTab" role="tablist"> <li class="nav-item" role="presentation"> <a class="nav-link active " id="pane-0" data-bs-toggle="tab" data-bs-target="#pane0" role="tab" aria-controls="pane0" aria-selected="true">Americas</a> </li> <li class="nav-item" role="presentation"> <a class="nav-link " id="pane-1" data-bs-toggle="tab" data-bs-target="#pane1" role="tab" aria-controls="pane1" aria-selected="true">Asia Pacific</a> </li> <li class="nav-item" role="presentation"> <a class="nav-link " id="pane-2" data-bs-toggle="tab" data-bs-target="#pane2" role="tab" aria-controls="pane2" aria-selected="true">Europe</a> </li> </ul> <div class="tab-content" id="myTabContent"> <div class="tab-pane fade show active " id="pane0" role="tabpanel" aria-labelledby="pane-0"> <ul class="americas"> <li><a href="https://www.ipsen.com/us/" target="_blank">United States</a> </li> <li><a href="https://www.ipsen.com/brazil/" target="_blank">Brazil</a> </li> <li><a href="https://www.ipsen.com/canada/" target="_blank">Canada</a> </li> <li><a href="https://www.ipsen.com/mx/" target="_blank">Mexico</a> </li> </ul> </div> <div class="tab-pane fade show " id="pane1" role="tabpanel" aria-labelledby="pane-1"> <ul class="asia-pacific"> <li><a href="https://www.ipsen.com/aus/" target="_blank">Australia</a> </li> <li><a href="https://www.ipsen.com/cn/" target="_blank">China</a> </li> <li><a href="https://www.ipsen.com/singapore/" target="_blank">Singapore</a> </li> <li><a href="https://www.ipsen.com/korea/" target="_blank">South Korea</a> </li> <li><a href="https://www.ipsen.com/japan/" target="_blank">Japan</a> </li> </ul> </div> <div class="tab-pane fade show " id="pane2" role="tabpanel" aria-labelledby="pane-2"> <ul class="europe"> <li><a href="https://www.ipsen.com/be/" target="_blank">Belgium</a> </li> <li><a href="https://www.ipsen.com/ukraine/" target="_blank">Ukraine</a> </li> <li><a href="https://www.ipsen.com/uk-ireland/" target="_blank">UK</a> </li> <li><a href="https://www.ipsen.com/germany/" target="_blank">Germany</a> </li> <li><a href="https://www.ipsen.com/france/" target="_blank">France</a> </li> <li><a href="https://www.ipsennordic.com/" target="_blank">Nordics</a> </li> <li><a href="https://www.ipsen.com/greece/" target="_blank">Greece</a> </li> <li><a href="https://www.ipsen.com/it/" target="_blank">Italy</a> </li> <li><a href="https://www.ipsen.com/netherlands/" target="_blank">Netherlands</a> </li> <li><a href="https://www.ipsen.com/spain/" target="_blank">Spain</a> </li> <li><a href="https://www.ipsen.com/poland/" target="_blank">Poland</a> </li> <li><a href="https://www.ipsen.com/russia/" target="_blank">Russia</a> </li> <li><a href="https://www.ipsen.com/czc/" target="_blank">Czech Republic</a> </li> <li><a href="https://www.ipsen.com/switzerland/" target="_blank">Switzerland</a> </li> </ul> </div> </div> </div> </div> </form> </li> </ul> <div class="col-md-12 col-sm-12"> <ul class="navbar-nav"> <li class="nav-item "> <a class="nav-link cool-link " target="_self" aria-current="page" href="https://www.ipsen.com/">Home</a> </li> <li class="nav-item dropdown"> <a href="#" class="nav-link cool-link" role="button" data-bs-toggle="dropdown" data-bs-auto-close="outside" aria-expanded="false">Company<img src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/down.png" alt="arrow_down" title="arrow_down" ></a> <ul class="dropdown-menu submenu" aria-labelledby="navbarDropdown"> <div class="go-back-menu mobile-view"> < Back </div> <li> <a class="nav-link cool-link active mobile-view">Company</a></li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/company/">Company </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/company/leadership-team/">Leadership </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/company/history/">History </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/company/foundation-ipsen/">Fondation Ipsen </a> </li> </ul> <li class="nav-item dropdown"> <a href="#" class="nav-link cool-link" role="button" data-bs-toggle="dropdown" data-bs-auto-close="outside" aria-expanded="false">Science<img src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/down.png" alt="arrow_down" title="arrow_down" ></a> <ul class="dropdown-menu submenu" aria-labelledby="navbarDropdown"> <div class="go-back-menu mobile-view"> < Back </div> <li> <a class="nav-link cool-link active mobile-view">Science</a></li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/oncology/">Oncology </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/rare-diseases/">Rare Disease </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/neuroscience/">Neuroscience </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/our-products/">Products </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/research-and-development/">R&D </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/pipeline/">Pipeline </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/clinical-trials/">Clinical Trials </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/lay-summaries/">Lay Summaries </a> </li> </ul> <li class="nav-item dropdown"> <a href="#" class="nav-link cool-link" role="button" data-bs-toggle="dropdown" data-bs-auto-close="outside" aria-expanded="false">Sustainability<img src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/down.png" alt="arrow_down" title="arrow_down" ></a> <ul class="dropdown-menu submenu" aria-labelledby="navbarDropdown"> <div class="go-back-menu mobile-view"> < Back </div> <li> <a class="nav-link cool-link active mobile-view">Sustainability</a></li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/sustainability/">Sustainability </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/sustainability/environment/">Environment </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/sustainability/patients/">Patients </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/sustainability/people/">People </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/sustainability/governance/">Governance </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/sustainability/our-standards/">Our Standards </a> </li> </ul> <li class="nav-item dropdown"> <a href="#" class="nav-link cool-link" role="button" data-bs-toggle="dropdown" data-bs-auto-close="outside" aria-expanded="false">Patients<img src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/down.png" alt="arrow_down" title="arrow_down" ></a> <ul class="dropdown-menu submenu" aria-labelledby="navbarDropdown"> <div class="go-back-menu mobile-view"> < Back </div> <li> <a class="nav-link cool-link active mobile-view">Patients</a></li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/patients/">Patients </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/patients/together-for-oncology/">Together for Oncology </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/patients/together-for-rare-disease/">Together for Rare Disease </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/patients/together-for-neuroscience/">Together for Neuroscience </a> </li> <li><a class="dropdown-item submenu-item" href="https://www.ipsen.com/patients/collaborate-with-us/">Collaborate with us </a> </li> </ul> <li class="nav-item "> <a class="nav-link cool-link " target="_self" aria-current="page" href="https://www.ipsen.com/stories/">Stories</a> </li> </ul> </div> </div> </div> </nav>  </div> </div> </section>   <div class="page-template single-post-template class="post-62834 press_release type-press_release status-publish hentry category-corporate-pressrelease category-rare-diseases-pressrelease entry"" id="post-62834"> <div class="main-container" role="main" id="main">  <section class="sub-page-banner " style="background: linear-gradient(93.64deg, #224A81 2.99%, #2797D3 97.01%)"> <div class="container content-sec"> <nav aria-label="breadcrumb"> <ol class="breadcrumb"> <li class="breadcrumb-item"><a href="https://www.ipsen.com">Home</a></li><li class="breadcrumb-item"><a href="">Press Releases</a></li><li class="breadcrumb-item active" aria-current="page">Corporate press releases</li></ol> </nav> <h1 class="hidden">Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases</h1> <p class="hidden"></p> </div> </section>  <div class="container"> <div class="page-navigation"> <div class="page-back"> <a href=""><span class="back-button">Back</span></a> </div> <div class="next-prev-sect"> <nav class="navigation post-navigation" aria-label="Posts"> <h2 class="screen-reader-text">Post navigation</h2> <div class="nav-links"><div class="nav-previous"><a href="https://www.ipsen.com/press-releases/ipsen-s-a-publishes-its-2024-half-year-report-half-year-ended-30-june-2024-2918797/" rel="prev"><span class="prev-button">Previous</span></a></div><div class="nav-next"><a href="https://www.ipsen.com/press-releases/ipsen-buy-back-programme-art-5-of-mar-week-30-2024-2921239/" rel="next"><span class="next-button">Next</span></a></div></div> </nav> </div> </div> <div class="row" id="downloadPdf" data-title="Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases" > <div class="generate-pdf hidden">  <h3 class="page-head">Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases</h3> <div class="content_area"> <ul type="disc"> <li style="margin-top: 6pt; text-align: justify;"><strong><em>CHMP positive opinion for Iqirvo</em></strong><sup><strong><em>®</em></strong></sup><strong><em> (elafibranor) recommended for the treatment of primary biliary cholangitis, following FDA approval in June 2024 </em></strong></li> <li style="margin-top: 6pt; text-align: justify;"><strong><em> CHMP positive opinion for Kayfanda</em></strong><sup><strong><em>®</em></strong></sup><strong><em> (odevixibat) recommended for cholestatic pruritus in patients with Alagille syndrome</em></strong></li> <li style="margin-top: 6pt; text-align: justify;"><strong><em>Final European Commission decision for both medicines expected in Q3 2024</em></strong></li> <li style="margin-top: 6pt; text-align: justify;"><strong><em>Ipsen continues to build leading rare cholestatic liver disease portfolio with these two new indications anticipated for approval in Europe</em></strong></li> </ul> <p align="justify"><strong>PARIS, FRANCE, 26 July 2024 – </strong>Ipsen (Euronext: IPN; ADR: IPSEY) announced today two positive opinions by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for two different rare cholestatic liver disease medicines from the company’s growing portfolio. Iqirvo<sup>®</sup> (elafibranor) has been recommended for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. Kayfanda<sup>®</sup> (odevixibat) has also received a positive opinion from CHMP as a treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older. The European Commission will now consider the CHMP recommendations. Final decisions on marketing authorization for Iqirvo and for Kayfanda are anticipated in Q3, 2024.</p> <p align="justify">“We are delighted to have received CHMP positive opinions for two potential new medicines in rare cholestatic liver diseases, on the same day. A rare achievement, and one that demonstrates our commitment to addressing the unmet medical needs in these diseases, said Christelle Huguet, Executive Vice President, Head of R&D. “PBC can progress to liver damage and even liver failure without effective therapies. Today’s decision takes us closer to being able to offer Iqirvo as a new treatment for patients, which significantly improves biomarkers that predict disease progression, without worsening symptoms. Also, with the positive opinion for Kayfanda we are moving forward in our efforts to provide a new treatment option for children with Alagille Syndrome, whose liver health can deteriorate rapidly and who often endure a very poor quality of life.”</p> <p align="justify"><strong>Iqirvo and PBC</strong></p> <p align="justify">Iqirvo is a first-in-class, oral, peroxisome proliferator-activated receptor (PPAR) agonist. Iqirvo was in-licensed by Ipsen from Genfit in 2021. The CHMP positive opinion is based mainly on data from the Phase III ELATIVE trial. The composite endpoint was achieved with results demonstrating statistically significant improvements in alkaline phosphatase (ALP) and total bilirubin (TB), biomarkers of PBC disease progression. For the key secondary endpoint using the PBC Worst Itch NRS score a trend towards improvement in pruritus (itch) was observed for elafibranor versus placebo, which was not statistically significant. Two other secondary patient-reported outcome measures were used to assess itch, and greater reductions were observed with Iqirvo compared with placebo at Week 52, according to the itch domain of PBC-40 quality of life questionnaire (LS mean difference -2.3; 95% CI, -4.0 to -0.7) and 5-D Itch total score (LS mean difference, -3.0; 95% CI, -5.5 to -0.5).<sup>1</sup></p> <p align="justify">“PBC is a progressive disease with a high number of patients who either don’t respond or can’t tolerate the current available treatments. This can result in ongoing disease progression, which may not be picked up until the patient’s next doctor’s appointment, which can be as long as 12 months between visits in some cases,” said Professor Marco Carbone, Professor of Gastroenterology, University of Milano-Bicocca and Consultant Hepatologist, the Niguarda Liver Transplant Centre, Milan. “It is important that we not only regularly review our PBC patients to ensure the levels of alkaline phosphatase, or ALP, and bilirubin are within normal limits, but that we also discuss symptoms that might impair patients’ quality of life potentially leading to withdrawal from current treatments.”</p> <p align="justify">“It is helpful for people diagnosed with PBC to understand that disease progression is monitored through levels of biomarkers in the blood, such as ALP,” said Patient Advocate, Mrs Sindee Weinbaum from European Liver Patients’ Association. “Being aware of these levels helps the person living with PBC to be more in control of their condition and to have constructive conversations with their doctor about how to control their symptoms and about what treatment is right for them. This is important for people living with PBC who can sometimes feel unheard.”</p> <p align="justify"><strong>Kayfanda and Alagille Syndrome</strong></p> <p align="justify">Kayfanda’s CHMP positive opinion is based on the ASSERT Phase III clinical trial data, presented at the 2022 American Association for the Study of Liver Disease (AASLD) congress and recently published in <em>Lancet Gastroenterology & Hepatology</em>.<sup>2</sup> ASSERT is the world’s first and only Phase III trial completed in patients with ALGS. The data demonstrated efficacy of odevixibat in pruritus, a measure of treatment benefit, based on the worst scratching score using an observer-reported outcome instrument. Results demonstrated statistically significant and clinically meaningful improvements from baseline to month 6, in scratching severity, for odevixibat versus placebo, which was seen rapidly and maintained over the study period.</p> <p align="justify">“Effective and well-tolerated treatments that can manage the debilitating itch caused by Alagille Syndrome and reduce the concentration of bile acids in the blood, are of great importance in our management and care of children with this condition and it is a positive development that there may soon be a new treatment option available,” said Professor Henkjan Verkade, Pediatric Gastroenterology and Hepatology, Department of Pediatrics, University of Groningen, Beatrix Children’s Hospital and University Medical Center Groningen, Netherlands. “This condition leads to multiple complications, it is however the intense itch experienced by these children and resulting sleep disturbances that is reported by the vast majority of people living with and caring for a child with liver disease due to Alagille Syndrome, as being the most significant.”</p> <p align="justify">In the ASSERT trial efficacy was also demonstrated on the key secondary endpoint showing a statistically significant reduction in serum bile acid concentration at the end of treatment for patients on odevixibat compared to placebo. Consistent with the improvements observed in pruritus, treatment with odevixibat led to significant improvements in multiple observer-reported outcome sleep parameters. The overall incidence of treatment emergent adverse events with odevixibat was similar to placebo, with a low drug-related diarrhea rate in patients with ALGS. All patients completed the study and 50 out of 52 patients have joined the extension study with all receiving odevixibat.<sup>2</sup></p> <p align="center"><strong>ENDS</strong></p> <p align="justify"><strong>About PBC</strong><br /> PBC is a rare, autoimmune, cholestatic liver disease, affecting approximately nine women for every one man. A build-up of bile and toxins (cholestasis) and chronic inflammation causes fibrosis (scarring) of the liver and destruction of the bile ducts. It is a life-long condition that can worsen over time if not effectively treated, leading to liver transplant and in some cases, premature death. PBC impacts patients’ daily lives through debilitating symptoms including most commonly pruritus and fatigue. Currently, there are no approved treatments available that can effectively manage both disease progression and life-impacting symptoms.</p> <p align="justify"><strong>About Iqirvo</strong><sup>®</sup><strong> (elafibranor) </strong><br /> Iqirvo® (pronounced EYE-KER-VO) is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR) agonist, which exerts an effect on PPARα and PPARδ, which are thought to be key regulators of bile acid (BA) homeostasis, inflammation and fibrosis. Pharmacological activity that is potentially relevant to Iqirvo therapeutic effects includes inhibition of bile acid synthesis through activation of PPARα and PPARδ. The proposed indication is for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. In 2019, Iqirvo was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA). UCDA being the existing first-line therapy for PBC. Iqirvo has not received approval by regulatory authorities outside of the U.S. Iqirvo is currently under regulatory review awaiting a final decision from the European Commission. It is also in regulatory processes with other authorities including the UK Medicines and Healthcare products Regulatory Agency (MHRA). Iqirvo (elafibranor) was discovered and developed by Genfit and Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from Genfit in 2021.</p> <p align="justify"><strong>About ELATIVE </strong><br /> ELATIVE<sup>1</sup> is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial, with an open-label long-term extension (NCT04526665). ELATIVE evaluated the efficacy and safety of elafibranor 80mg once daily versus placebo for the treatment of patients with PBC with an inadequate response or intolerance to ursodeoxycholic acid (UDCA), the existing first-line therapy for PBC. The trial enrolled 161 patients who were randomized 2:1 to receive elafibranor 80mg once daily or placebo. Patients with an inadequate response to UDCA would continue to receive UDCA in combination with elafibranor or placebo, while patients unable to tolerate UDCA would receive only elafibranor or placebo. Patients continued their assigned treatment after Week 52 until all patients had completed their treatment or for a maximum of 104 weeks. Data was also collected during this period, and additional analyses were conducted with a focus on Week 78.</p> <p align="justify">In the trial, results show statistically significant improvements in the primary composite endpoint of biochemical response, defined as alkaline phosphatase (ALP) <1.67 x upper limit of normal (ULN), an ALP decrease ≥ 15 percent and total bilirubin (TB) ≤ ULN at 52 weeks, with a significant treatment benefit demonstrating a 47% placebo-adjusted difference (P<0.001) between patients on elafibranor 80mg (51%) compared with patients on placebo (4%) achieving a biochemical response. ALP and bilirubin are important predictors of PBC disease progression. Reductions in levels of both can indicate reduced cholestatic injury and improved liver function.</p> <p align="justify">Only patients receiving elafibranor achieved normalization of ALP (upper limit of normal 104 U/L in females and 129 U/L in males) at Week 52 (15% vs 0% placebo, P=0.002), a key secondary endpoint of the trial. The significant biochemical effect of elafibranor measured by ALP reduction was further supported by data demonstrating reductions from baseline in ALP levels were rapid, seen as early as Week 4 in the elafibranor group, and were sustained through Week 52, with a decrease in ALP of 41% on elafibranor compared with placebo.</p> <p align="justify">Elafibranor was well tolerated in the trial. Similar percentages of patients in the treatment group and the placebo group experienced adverse events, treatment-related adverse events, severe or serious adverse events or adverse events leading to discontinuation. Adverse events occurring in >10% of patients and more frequently on elafibranor versus placebo included abdominal pain, diarrhea, nausea, and vomiting.</p> <p align="justify"><strong>About ALGS </strong><br /> ALGS is an inherited rare, genetic disorder that can affect multiple organs including the liver, heart, skeleton, eyes and kidneys. Liver damage may result from having fewer than normal, narrowed or malformed bile ducts, which leads to a build-up of toxic bile acid, known as cholestasis and this in turn can cause fibrosis and progressive liver disease. Approximately 95% of patients with the condition present with chronic cholestasis, usually within the first three months of life and as many as 88% also present with severe, intractable pruritus or itch. The estimated global incidence of ALGS is 3 in 100,000 live births.</p> <p align="justify"><strong>About Kayfanda</strong><sup>®</sup><strong> (odevixibat)</strong><br /> Kaydanda<sup>®</sup> (odevixibat) is a once-daily non-systemic ileal bile acid transport (IBAT) inhibitor being investigated in the E.U. for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older. Odevixibat was approved in June 2021 in the E.U. under the brand name Bylvay <sup>®</sup>, as the first drug treatment option for all types of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older, and in the U.S. under the brand name Bylvay®, as the first drug treatment option for patients 3 months of age and older living with cholestatic pruritus due to PFIC. Bylvay has received orphan exclusivity for the treatment of PFIC in the E.U. and in the U.S. In June 2023 Bylvay was approved in the U.S. for the treatment of cholestatic pruritus in patients from 12 months of age with ALGS and received orphan exclusivity for ALGS. In October 2023, while the EMA’s CHMP recommended the approval of Bylvay in ALGS, the EMA’s Committee for Orphan Medicinal Products (COMP) recommended not to maintain orphan exclusivity in the E.U. for Bylvay in ALGS. In order to ensure sustainable access and availability for Bylvay in the approved indication for the treatment of PFIC, which is supported by orphan drug status, odevixibat for the treatment of ALGS has been resubmitted to the EMA under a new brand name, Kayfanda, without orphan designation and is currently awaiting a final decision from the European Commission.</p> <p align="justify"><strong>About ASSERT</strong><br /> ASSERT<sup>2</sup> is a double-blind, randomized, placebo-controlled trial designed to evaluate the safety and efficacy of 120 µg/kg/day Bylvay (odevixibat) for 24 weeks in relieving pruritus in patients with ALGS conducted in 52 patients with 32 sites across North America, Europe, Middle East, and Asia Pacific.</p> <p align="justify">The trial enrolled patients aged 0 to 17 years of age with a genetically confirmed diagnosis of ALGS. In the primary analysis, the study met the primary endpoint showing highly statistically significant improvement in pruritus for patients on odevixibat as measured by the PRUCISION Observer-Reported Outcome scratching score (0-4 point scale), from baseline at month 6 (weeks 21 to 24), compared to the placebo arm (p=0.002). More than 90% of patients were pruritus responders (≥ 1 point change at any time during 24 weeks).</p> <p align="justify">The study also met the key secondary endpoint showing a highly statistically significant reduction in serum bile acid concentration from baseline to the average of weeks 20 and 24 (compared to the placebo arm p=0.001). Statistically significant improvements in multiple sleep parameters were observed as early as weeks 1-4 compared to patients on placebo with continued improvement through week 24.</p> <p align="justify">In the study, there were no patient discontinuations and 96% of patients rolled over into the open-label extension study. Bylvay had an overall adverse event incidence similar to placebo and a low incidence of drug-related diarrhea (11.4% vs. 5.9% placebo).</p> <p align="justify">The detailed recommendations for the use of odevixibat are described in the <a title="" href="https://www.globenewswire.com/Tracker?data=eR_vR8FRkFuFStITBJPSU7EC6PdHxUiCMo1bED3ZTFP_QbjPRHhDz2BPAU9uirXETWUpiJap8hWpu3cpT-0s79EY6daM8D2BiLafCiyRFAusiA2h7Hiq1HE_Q6xll2oSbTaiehlan2Kfi0V5Di3hnn7UHwScNNG5H7Z_s-4RkU_QVYOg5b31LwhqO1DivaXYt-qCdPYR2a0FAkhGNb1bj2uhAUKJ_aLWMwdgPoZxnT4=" target="_blank" rel="nofollow noopener"><strong>Summary of Product Characteristics (EU SmPC)</strong></a> and <a title="" href="https://www.globenewswire.com/Tracker?data=VKcvJRmAtfktyjgNrFsqbrwuvx9zAXeFRK6ZczYz69gcUyQOTSyPpau2Zf6ZPvhUb2AfRgsikEZDxoPxmOFiSufAY6LfBmMCBhSi2gQ772TfWOcoOxMLljTqZ0qIBd6lSKEBvHiFFWIjGvo9Pilwci_tcMK3QMaA4-iDpgDKFjEIkltQ4QA9kgSjeJfBvI8X" target="_blank" rel="nofollow noopener"><strong>U.S. Prescribing Information (USPI)</strong></a></p> <p align="justify"><strong>About Ipsen </strong></p> <p align="justify">We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.</p> <p align="justify">Our pipeline is fuelled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries.</p> <p align="justify">Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.</p> <p align="justify"><strong>Ipsen contacts </strong></p> <p align="justify"><strong>Investors</strong></p> <ul type="disc"> <li style="margin-bottom: 6pt; text-align: justify;"><strong>Craig Marks | + 44 (0)7584 34 91 93 | craig.marks@ipsen.com</strong></li> <li style="margin-bottom: 6pt; text-align: justify;"><strong>Nicolas Bogler | + 33 6 52 19 98 92 | nicolas.bogler@ipsen.com</strong></li> </ul> <p align="justify"><strong>Media</strong></p> <ul type="disc"> <li style="margin-bottom: 6pt; text-align: justify;"><strong>Amy Wolf | + 41 79 576 07 23 | amy.wolf@ipsen.com</strong></li> <li style="margin-bottom: 6pt; text-align: justify;"><strong>Anna Gibbins | + 44 7717 80 19 00| anna.gibbins@ipsen.com</strong></li> </ul> <p align="justify"><strong>Disclaimers and/or Forward-Looking Statements</strong></p> <p>The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on <a title="ipsen.com" href="https://www.globenewswire.com/Tracker?data=-L5rjz9_k0bjAow82299K5FnjW7wiWYGkx3Oq8o3zn6XbggLB2P3MK7fhSqkMcm5Tub86Nqa28HLQ5ZqQ5FvOL1fXQyoIFFLJC-0ti4Gsb5KbWrnB8Q1OPeeJ5mz5elGqoVB7z3Wg24V46eBSqPMgWpuZnBQTBcZOF5wCsVdQ5KTOI6laQfWXA_bUEnQ0A3HuI9-adV5lugvj47x12JIXOTNFydtWJvP5qmHTsyY68U=" target="_blank" rel="nofollow noopener">ipsen.com</a>.</p> <p align="justify"><strong>References </strong></p> <ol style="list-style-type: decimal;"> <li style="text-align: justify;">Kowdley. K.V, et al. Efficacy and Safety of Elafibranor in Primary Biliary Cholangitis. NEJM. 2023. DOI: 10.1056/NEJMoa2306185</li> <li style="text-align: justify;">Ovchinsky N., et al. Efficacy and safety of odevixibat in patients with Alagille syndrome (ASSRT); a phase 3, double-blind, randomized, placebo-controlled trial. Lancet Gastroenterol / Hepatol. 2024 doi.org/10.1016/S2468-1253(24)00074-8</li> </ol> <p id="gnw_attachments_section-header"><strong>Attachment</strong></p> <ul id="gnw_attachments_section-items"> <li><a title="PR_CHMP_Iqirvo and Kayfanda_260724" href="https://www.globenewswire.com/Tracker?data=ojgCEU2MNKgL8j8Lo73va5gcFTjkL51lJDMW3-c3QM87lq8yQRlAMN4taa8eNIphkWNeXq70CUryj-sqk68_Pi3BdaxJcYoeCmytmnSguaDmRl5_eG6q9naEk_RIY9jcjFy1p3nZhgWpH8OJk_ZUgGJct9NihphkPOenxVpC02IQ8hLzzTgo0Nnob6Ahc3jI" target="_blank" rel="nofollow noopener">PR_CHMP_Iqirvo and Kayfanda_260724</a></li> </ul> <p><img decoding="async" src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" data-lazy-src="https://ml-eu.globenewswire.com/media/ZGUwMWU1NmQtYWE3NC00YzQ0LTk1NDItM2UxZjg2NjE2MzU0LTEyNjgxMTY=/tiny/Ipsen-Pharma.png" /><noscript><img decoding="async" src="https://ml-eu.globenewswire.com/media/ZGUwMWU1NmQtYWE3NC00YzQ0LTk1NDItM2UxZjg2NjE2MzU0LTEyNjgxMTY=/tiny/Ipsen-Pharma.png" /></noscript></p> </div> </div> <div class="left-post-side column-1 col-xl-12 col-lg-12 col-md-12 col-sm-12"> <h3 class="page-head">Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases</h3> <div class="story-info-sec"> <button class="btn tag-btn green-btn" style="background-color:#7dc1e5;"> Rare Diseases </button> <span class="desk-span"> - <span class="story-date">26 July 2024</span> - <span class="story-read-time">12 mins read</span></span> </div> <div class="page-filter-tags"> </div> <div class="content_area"> <ul type="disc"> <li style="margin-top: 6pt; text-align: justify;"><strong><em>CHMP positive opinion for Iqirvo</em></strong><sup><strong><em>®</em></strong></sup><strong><em> (elafibranor) recommended for the treatment of primary biliary cholangitis, following FDA approval in June 2024 </em></strong></li> <li style="margin-top: 6pt; text-align: justify;"><strong><em> CHMP positive opinion for Kayfanda</em></strong><sup><strong><em>®</em></strong></sup><strong><em> (odevixibat) recommended for cholestatic pruritus in patients with Alagille syndrome</em></strong></li> <li style="margin-top: 6pt; text-align: justify;"><strong><em>Final European Commission decision for both medicines expected in Q3 2024</em></strong></li> <li style="margin-top: 6pt; text-align: justify;"><strong><em>Ipsen continues to build leading rare cholestatic liver disease portfolio with these two new indications anticipated for approval in Europe</em></strong></li> </ul> <p align="justify"><strong>PARIS, FRANCE, 26 July 2024 – </strong>Ipsen (Euronext: IPN; ADR: IPSEY) announced today two positive opinions by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for two different rare cholestatic liver disease medicines from the company’s growing portfolio. Iqirvo<sup>®</sup> (elafibranor) has been recommended for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. Kayfanda<sup>®</sup> (odevixibat) has also received a positive opinion from CHMP as a treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older. The European Commission will now consider the CHMP recommendations. Final decisions on marketing authorization for Iqirvo and for Kayfanda are anticipated in Q3, 2024.</p> <p align="justify">“We are delighted to have received CHMP positive opinions for two potential new medicines in rare cholestatic liver diseases, on the same day. A rare achievement, and one that demonstrates our commitment to addressing the unmet medical needs in these diseases, said Christelle Huguet, Executive Vice President, Head of R&D. “PBC can progress to liver damage and even liver failure without effective therapies. Today’s decision takes us closer to being able to offer Iqirvo as a new treatment for patients, which significantly improves biomarkers that predict disease progression, without worsening symptoms. Also, with the positive opinion for Kayfanda we are moving forward in our efforts to provide a new treatment option for children with Alagille Syndrome, whose liver health can deteriorate rapidly and who often endure a very poor quality of life.”</p> <p align="justify"><strong>Iqirvo and PBC</strong></p> <p align="justify">Iqirvo is a first-in-class, oral, peroxisome proliferator-activated receptor (PPAR) agonist. Iqirvo was in-licensed by Ipsen from Genfit in 2021. The CHMP positive opinion is based mainly on data from the Phase III ELATIVE trial. The composite endpoint was achieved with results demonstrating statistically significant improvements in alkaline phosphatase (ALP) and total bilirubin (TB), biomarkers of PBC disease progression. For the key secondary endpoint using the PBC Worst Itch NRS score a trend towards improvement in pruritus (itch) was observed for elafibranor versus placebo, which was not statistically significant. Two other secondary patient-reported outcome measures were used to assess itch, and greater reductions were observed with Iqirvo compared with placebo at Week 52, according to the itch domain of PBC-40 quality of life questionnaire (LS mean difference -2.3; 95% CI, -4.0 to -0.7) and 5-D Itch total score (LS mean difference, -3.0; 95% CI, -5.5 to -0.5).<sup>1</sup></p> <p align="justify">“PBC is a progressive disease with a high number of patients who either don’t respond or can’t tolerate the current available treatments. This can result in ongoing disease progression, which may not be picked up until the patient’s next doctor’s appointment, which can be as long as 12 months between visits in some cases,” said Professor Marco Carbone, Professor of Gastroenterology, University of Milano-Bicocca and Consultant Hepatologist, the Niguarda Liver Transplant Centre, Milan. “It is important that we not only regularly review our PBC patients to ensure the levels of alkaline phosphatase, or ALP, and bilirubin are within normal limits, but that we also discuss symptoms that might impair patients’ quality of life potentially leading to withdrawal from current treatments.”</p> <p align="justify">“It is helpful for people diagnosed with PBC to understand that disease progression is monitored through levels of biomarkers in the blood, such as ALP,” said Patient Advocate, Mrs Sindee Weinbaum from European Liver Patients’ Association. “Being aware of these levels helps the person living with PBC to be more in control of their condition and to have constructive conversations with their doctor about how to control their symptoms and about what treatment is right for them. This is important for people living with PBC who can sometimes feel unheard.”</p> <p align="justify"><strong>Kayfanda and Alagille Syndrome</strong></p> <p align="justify">Kayfanda’s CHMP positive opinion is based on the ASSERT Phase III clinical trial data, presented at the 2022 American Association for the Study of Liver Disease (AASLD) congress and recently published in <em>Lancet Gastroenterology & Hepatology</em>.<sup>2</sup> ASSERT is the world’s first and only Phase III trial completed in patients with ALGS. The data demonstrated efficacy of odevixibat in pruritus, a measure of treatment benefit, based on the worst scratching score using an observer-reported outcome instrument. Results demonstrated statistically significant and clinically meaningful improvements from baseline to month 6, in scratching severity, for odevixibat versus placebo, which was seen rapidly and maintained over the study period.</p> <p align="justify">“Effective and well-tolerated treatments that can manage the debilitating itch caused by Alagille Syndrome and reduce the concentration of bile acids in the blood, are of great importance in our management and care of children with this condition and it is a positive development that there may soon be a new treatment option available,” said Professor Henkjan Verkade, Pediatric Gastroenterology and Hepatology, Department of Pediatrics, University of Groningen, Beatrix Children’s Hospital and University Medical Center Groningen, Netherlands. “This condition leads to multiple complications, it is however the intense itch experienced by these children and resulting sleep disturbances that is reported by the vast majority of people living with and caring for a child with liver disease due to Alagille Syndrome, as being the most significant.”</p> <p align="justify">In the ASSERT trial efficacy was also demonstrated on the key secondary endpoint showing a statistically significant reduction in serum bile acid concentration at the end of treatment for patients on odevixibat compared to placebo. Consistent with the improvements observed in pruritus, treatment with odevixibat led to significant improvements in multiple observer-reported outcome sleep parameters. The overall incidence of treatment emergent adverse events with odevixibat was similar to placebo, with a low drug-related diarrhea rate in patients with ALGS. All patients completed the study and 50 out of 52 patients have joined the extension study with all receiving odevixibat.<sup>2</sup></p> <p align="center"><strong>ENDS</strong></p> <p align="justify"><strong>About PBC</strong><br /> PBC is a rare, autoimmune, cholestatic liver disease, affecting approximately nine women for every one man. A build-up of bile and toxins (cholestasis) and chronic inflammation causes fibrosis (scarring) of the liver and destruction of the bile ducts. It is a life-long condition that can worsen over time if not effectively treated, leading to liver transplant and in some cases, premature death. PBC impacts patients’ daily lives through debilitating symptoms including most commonly pruritus and fatigue. Currently, there are no approved treatments available that can effectively manage both disease progression and life-impacting symptoms.</p> <p align="justify"><strong>About Iqirvo</strong><sup>®</sup><strong> (elafibranor) </strong><br /> Iqirvo® (pronounced EYE-KER-VO) is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR) agonist, which exerts an effect on PPARα and PPARδ, which are thought to be key regulators of bile acid (BA) homeostasis, inflammation and fibrosis. Pharmacological activity that is potentially relevant to Iqirvo therapeutic effects includes inhibition of bile acid synthesis through activation of PPARα and PPARδ. The proposed indication is for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. In 2019, Iqirvo was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA). UCDA being the existing first-line therapy for PBC. Iqirvo has not received approval by regulatory authorities outside of the U.S. Iqirvo is currently under regulatory review awaiting a final decision from the European Commission. It is also in regulatory processes with other authorities including the UK Medicines and Healthcare products Regulatory Agency (MHRA). Iqirvo (elafibranor) was discovered and developed by Genfit and Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from Genfit in 2021.</p> <p align="justify"><strong>About ELATIVE </strong><br /> ELATIVE<sup>1</sup> is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial, with an open-label long-term extension (NCT04526665). ELATIVE evaluated the efficacy and safety of elafibranor 80mg once daily versus placebo for the treatment of patients with PBC with an inadequate response or intolerance to ursodeoxycholic acid (UDCA), the existing first-line therapy for PBC. The trial enrolled 161 patients who were randomized 2:1 to receive elafibranor 80mg once daily or placebo. Patients with an inadequate response to UDCA would continue to receive UDCA in combination with elafibranor or placebo, while patients unable to tolerate UDCA would receive only elafibranor or placebo. Patients continued their assigned treatment after Week 52 until all patients had completed their treatment or for a maximum of 104 weeks. Data was also collected during this period, and additional analyses were conducted with a focus on Week 78.</p> <p align="justify">In the trial, results show statistically significant improvements in the primary composite endpoint of biochemical response, defined as alkaline phosphatase (ALP) <1.67 x upper limit of normal (ULN), an ALP decrease ≥ 15 percent and total bilirubin (TB) ≤ ULN at 52 weeks, with a significant treatment benefit demonstrating a 47% placebo-adjusted difference (P<0.001) between patients on elafibranor 80mg (51%) compared with patients on placebo (4%) achieving a biochemical response. ALP and bilirubin are important predictors of PBC disease progression. Reductions in levels of both can indicate reduced cholestatic injury and improved liver function.</p> <p align="justify">Only patients receiving elafibranor achieved normalization of ALP (upper limit of normal 104 U/L in females and 129 U/L in males) at Week 52 (15% vs 0% placebo, P=0.002), a key secondary endpoint of the trial. The significant biochemical effect of elafibranor measured by ALP reduction was further supported by data demonstrating reductions from baseline in ALP levels were rapid, seen as early as Week 4 in the elafibranor group, and were sustained through Week 52, with a decrease in ALP of 41% on elafibranor compared with placebo.</p> <p align="justify">Elafibranor was well tolerated in the trial. Similar percentages of patients in the treatment group and the placebo group experienced adverse events, treatment-related adverse events, severe or serious adverse events or adverse events leading to discontinuation. Adverse events occurring in >10% of patients and more frequently on elafibranor versus placebo included abdominal pain, diarrhea, nausea, and vomiting.</p> <p align="justify"><strong>About ALGS </strong><br /> ALGS is an inherited rare, genetic disorder that can affect multiple organs including the liver, heart, skeleton, eyes and kidneys. Liver damage may result from having fewer than normal, narrowed or malformed bile ducts, which leads to a build-up of toxic bile acid, known as cholestasis and this in turn can cause fibrosis and progressive liver disease. Approximately 95% of patients with the condition present with chronic cholestasis, usually within the first three months of life and as many as 88% also present with severe, intractable pruritus or itch. The estimated global incidence of ALGS is 3 in 100,000 live births.</p> <p align="justify"><strong>About Kayfanda</strong><sup>®</sup><strong> (odevixibat)</strong><br /> Kaydanda<sup>®</sup> (odevixibat) is a once-daily non-systemic ileal bile acid transport (IBAT) inhibitor being investigated in the E.U. for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older. Odevixibat was approved in June 2021 in the E.U. under the brand name Bylvay <sup>®</sup>, as the first drug treatment option for all types of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older, and in the U.S. under the brand name Bylvay®, as the first drug treatment option for patients 3 months of age and older living with cholestatic pruritus due to PFIC. Bylvay has received orphan exclusivity for the treatment of PFIC in the E.U. and in the U.S. In June 2023 Bylvay was approved in the U.S. for the treatment of cholestatic pruritus in patients from 12 months of age with ALGS and received orphan exclusivity for ALGS. In October 2023, while the EMA’s CHMP recommended the approval of Bylvay in ALGS, the EMA’s Committee for Orphan Medicinal Products (COMP) recommended not to maintain orphan exclusivity in the E.U. for Bylvay in ALGS. In order to ensure sustainable access and availability for Bylvay in the approved indication for the treatment of PFIC, which is supported by orphan drug status, odevixibat for the treatment of ALGS has been resubmitted to the EMA under a new brand name, Kayfanda, without orphan designation and is currently awaiting a final decision from the European Commission.</p> <p align="justify"><strong>About ASSERT</strong><br /> ASSERT<sup>2</sup> is a double-blind, randomized, placebo-controlled trial designed to evaluate the safety and efficacy of 120 µg/kg/day Bylvay (odevixibat) for 24 weeks in relieving pruritus in patients with ALGS conducted in 52 patients with 32 sites across North America, Europe, Middle East, and Asia Pacific.</p> <p align="justify">The trial enrolled patients aged 0 to 17 years of age with a genetically confirmed diagnosis of ALGS. In the primary analysis, the study met the primary endpoint showing highly statistically significant improvement in pruritus for patients on odevixibat as measured by the PRUCISION Observer-Reported Outcome scratching score (0-4 point scale), from baseline at month 6 (weeks 21 to 24), compared to the placebo arm (p=0.002). More than 90% of patients were pruritus responders (≥ 1 point change at any time during 24 weeks).</p> <p align="justify">The study also met the key secondary endpoint showing a highly statistically significant reduction in serum bile acid concentration from baseline to the average of weeks 20 and 24 (compared to the placebo arm p=0.001). Statistically significant improvements in multiple sleep parameters were observed as early as weeks 1-4 compared to patients on placebo with continued improvement through week 24.</p> <p align="justify">In the study, there were no patient discontinuations and 96% of patients rolled over into the open-label extension study. Bylvay had an overall adverse event incidence similar to placebo and a low incidence of drug-related diarrhea (11.4% vs. 5.9% placebo).</p> <p align="justify">The detailed recommendations for the use of odevixibat are described in the <a title="" href="https://www.globenewswire.com/Tracker?data=eR_vR8FRkFuFStITBJPSU7EC6PdHxUiCMo1bED3ZTFP_QbjPRHhDz2BPAU9uirXETWUpiJap8hWpu3cpT-0s79EY6daM8D2BiLafCiyRFAusiA2h7Hiq1HE_Q6xll2oSbTaiehlan2Kfi0V5Di3hnn7UHwScNNG5H7Z_s-4RkU_QVYOg5b31LwhqO1DivaXYt-qCdPYR2a0FAkhGNb1bj2uhAUKJ_aLWMwdgPoZxnT4=" target="_blank" rel="nofollow noopener"><strong>Summary of Product Characteristics (EU SmPC)</strong></a> and <a title="" href="https://www.globenewswire.com/Tracker?data=VKcvJRmAtfktyjgNrFsqbrwuvx9zAXeFRK6ZczYz69gcUyQOTSyPpau2Zf6ZPvhUb2AfRgsikEZDxoPxmOFiSufAY6LfBmMCBhSi2gQ772TfWOcoOxMLljTqZ0qIBd6lSKEBvHiFFWIjGvo9Pilwci_tcMK3QMaA4-iDpgDKFjEIkltQ4QA9kgSjeJfBvI8X" target="_blank" rel="nofollow noopener"><strong>U.S. Prescribing Information (USPI)</strong></a></p> <p align="justify"><strong>About Ipsen </strong></p> <p align="justify">We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.</p> <p align="justify">Our pipeline is fuelled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries.</p> <p align="justify">Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.</p> <p align="justify"><strong>Ipsen contacts </strong></p> <p align="justify"><strong>Investors</strong></p> <ul type="disc"> <li style="margin-bottom: 6pt; text-align: justify;"><strong>Craig Marks | + 44 (0)7584 34 91 93 | craig.marks@ipsen.com</strong></li> <li style="margin-bottom: 6pt; text-align: justify;"><strong>Nicolas Bogler | + 33 6 52 19 98 92 | nicolas.bogler@ipsen.com</strong></li> </ul> <p align="justify"><strong>Media</strong></p> <ul type="disc"> <li style="margin-bottom: 6pt; text-align: justify;"><strong>Amy Wolf | + 41 79 576 07 23 | amy.wolf@ipsen.com</strong></li> <li style="margin-bottom: 6pt; text-align: justify;"><strong>Anna Gibbins | + 44 7717 80 19 00| anna.gibbins@ipsen.com</strong></li> </ul> <p align="justify"><strong>Disclaimers and/or Forward-Looking Statements</strong></p> <p>The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on <a title="ipsen.com" href="https://www.globenewswire.com/Tracker?data=-L5rjz9_k0bjAow82299K5FnjW7wiWYGkx3Oq8o3zn6XbggLB2P3MK7fhSqkMcm5Tub86Nqa28HLQ5ZqQ5FvOL1fXQyoIFFLJC-0ti4Gsb5KbWrnB8Q1OPeeJ5mz5elGqoVB7z3Wg24V46eBSqPMgWpuZnBQTBcZOF5wCsVdQ5KTOI6laQfWXA_bUEnQ0A3HuI9-adV5lugvj47x12JIXOTNFydtWJvP5qmHTsyY68U=" target="_blank" rel="nofollow noopener">ipsen.com</a>.</p> <p align="justify"><strong>References </strong></p> <ol style="list-style-type: decimal;"> <li style="text-align: justify;">Kowdley. K.V, et al. Efficacy and Safety of Elafibranor in Primary Biliary Cholangitis. NEJM. 2023. DOI: 10.1056/NEJMoa2306185</li> <li style="text-align: justify;">Ovchinsky N., et al. Efficacy and safety of odevixibat in patients with Alagille syndrome (ASSRT); a phase 3, double-blind, randomized, placebo-controlled trial. Lancet Gastroenterol / Hepatol. 2024 doi.org/10.1016/S2468-1253(24)00074-8</li> </ol> <p id="gnw_attachments_section-header"><strong>Attachment</strong></p> <ul id="gnw_attachments_section-items"> <li><a title="PR_CHMP_Iqirvo and Kayfanda_260724" href="https://www.globenewswire.com/Tracker?data=ojgCEU2MNKgL8j8Lo73va5gcFTjkL51lJDMW3-c3QM87lq8yQRlAMN4taa8eNIphkWNeXq70CUryj-sqk68_Pi3BdaxJcYoeCmytmnSguaDmRl5_eG6q9naEk_RIY9jcjFy1p3nZhgWpH8OJk_ZUgGJct9NihphkPOenxVpC02IQ8hLzzTgo0Nnob6Ahc3jI" target="_blank" rel="nofollow noopener">PR_CHMP_Iqirvo and Kayfanda_260724</a></li> </ul> <p><img decoding="async" src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" data-lazy-src="https://ml-eu.globenewswire.com/media/ZGUwMWU1NmQtYWE3NC00YzQ0LTk1NDItM2UxZjg2NjE2MzU0LTEyNjgxMTY=/tiny/Ipsen-Pharma.png" /><noscript><img decoding="async" src="https://ml-eu.globenewswire.com/media/ZGUwMWU1NmQtYWE3NC00YzQ0LTk1NDItM2UxZjg2NjE2MzU0LTEyNjgxMTY=/tiny/Ipsen-Pharma.png" /></noscript></p> </div> <div class="page-navigation bottom-page-nav"> <div class="next-prev-sect"> <nav class="navigation post-navigation" aria-label="Posts"> <h2 class="screen-reader-text">Post navigation</h2> <div class="nav-links"><div class="nav-previous"><a href="https://www.ipsen.com/press-releases/ipsen-s-a-publishes-its-2024-half-year-report-half-year-ended-30-june-2024-2918797/" rel="prev"><span class="prev-button">Previous</span></a></div><div class="nav-next"><a href="https://www.ipsen.com/press-releases/ipsen-buy-back-programme-art-5-of-mar-week-30-2024-2921239/" rel="next"><span class="next-button">Next</span></a></div></div> </nav> </div> </div> </div> <div class="right-post-side hidden">  <div class="side-panel-social-media"> </div>   <div class="side-panel-download-card"> </div>   <div class="side-panel-quicklink"> </div>   <div class="side-panel-comingevent"> </div>   <div class="side-panel-contact-card"> </div>  </div> <section class="p-slider related-story"> <div class="slider-heading-container"> <h2 class="slider-title">Related Press Releases</h2> </div>  <div class="slider-btns"> <button aria-label="Previous" aria-labelledby="glider-product-related-prev" role="button" title="Previous" class="glider-product-related-prev"> <span data-bg="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/blue-left-arrow.png" class="rocket-lazyload" style=""></span> </button> <button aria-label="Next" aria-labelledby="glider-product-related-next" role="button" title="Next" class="glider-product-related-next"> <span data-bg="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/blue-right-arrow.png" class="rocket-lazyload" style=""></span> </button> </div>  <div class="glider-contain multiple"> <div class="glider-product-related">  <a href="https://www.ipsen.com/press-releases/bylvay-odevixibat-data-shows-sustained-improvement-in-severe-itch-and-serum-bile-acid-levels-in-patients-with-pfic-and-algs-2982434/"> <div class="product-box">  <div class="p-img-container"> <div class="p-img"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" alt="Bylvay® (odevixibat) data shows sustained improvement in severe itch and serum bile acid levels in patients with PFIC and ALGS" title="Bylvay® (odevixibat) data shows sustained improvement in severe itch and serum bile acid levels in patients with PFIC and ALGS" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" ><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" alt="Bylvay® (odevixibat) data shows sustained improvement in severe itch and serum bile acid levels in patients with PFIC and ALGS" title="Bylvay® (odevixibat) data shows sustained improvement in severe itch and serum bile acid levels in patients with PFIC and ALGS" ></noscript> </div> </div>  <div class="p-box-text"> <button class="btn-link card-btn" style="background-color:#4e6e9a;"> Corporate </button> <span class="time-stamp">18 November 2024</span> <span class="time-stamp">12 mins read</span> <div class="text-div"> <h3>Bylvay® (odevixibat) data shows sustained improvement in severe itch and serum bile acid levels in patients with PFIC and ALGS</h3> </div> </div> </div> </a>  <a href="https://www.ipsen.com/press-releases/iqirvo-elafibranor-data-shows-efficacy-and-safety-for-up-to-3-years-in-patients-with-pbc-with-improvements-in-fatigue-and-pruritus-2982128/"> <div class="product-box">  <div class="p-img-container"> <div class="p-img"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" alt="Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritus" title="Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritus" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" ><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" alt="Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritus" title="Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritus" ></noscript> </div> </div>  <div class="p-box-text"> <button class="btn-link card-btn" style="background-color:#4e6e9a;"> Corporate </button> <span class="time-stamp">15 November 2024</span> <span class="time-stamp">12 mins read</span> <div class="text-div"> <h3>Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years in patients with PBC with improvements in fatigue and pruritus</h3> </div> </div> </div> </a>  <a href="https://www.ipsen.com/press-releases/ipsen-delivers-strong-sales-momentum-in-the-first-nine-months-of-2024-and-increases-its-full-year-guidance-2967449/"> <div class="product-box">  <div class="p-img-container"> <div class="p-img"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" alt="Ipsen delivers strong sales momentum in the first nine months of 2024 and increases its full-year guidance" title="Ipsen delivers strong sales momentum in the first nine months of 2024 and increases its full-year guidance" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" ><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" alt="Ipsen delivers strong sales momentum in the first nine months of 2024 and increases its full-year guidance" title="Ipsen delivers strong sales momentum in the first nine months of 2024 and increases its full-year guidance" ></noscript> </div> </div>  <div class="p-box-text"> <button class="btn-link card-btn" style="background-color:#4e6e9a;"> Corporate </button> <span class="time-stamp">23 October 2024</span> <span class="time-stamp">4 mins read</span> <div class="text-div"> <h3>Ipsen delivers strong sales momentum in the first nine months of 2024 and increases its full-year guidance</h3> </div> </div> </div> </a>  <a href="https://www.ipsen.com/press-releases/ipsen-receives-its-second-shingo-prize-for-operational-excellence-2962739/"> <div class="product-box">  <div class="p-img-container"> <div class="p-img"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" alt="Ipsen receives its second Shingo Prize for operational excellence" title="Ipsen receives its second Shingo Prize for operational excellence" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" ><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" alt="Ipsen receives its second Shingo Prize for operational excellence" title="Ipsen receives its second Shingo Prize for operational excellence" ></noscript> </div> </div>  <div class="p-box-text"> <button class="btn-link card-btn" style="background-color:#4e6e9a;"> Corporate </button> <span class="time-stamp">14 October 2024</span> <span class="time-stamp">5 mins read</span> <div class="text-div"> <h3>Ipsen receives its second Shingo Prize for operational excellence</h3> </div> </div> </div> </a>  <a href="https://www.ipsen.com/press-releases/ipsens-kayfanda-odevixibat-approved-in-european-union-for-cholestatic-pruritus-in-alagille-syndrome-a-rare-liver-disease-2951259/"> <div class="product-box">  <div class="p-img-container"> <div class="p-img"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" alt="Ipsen’s Kayfanda® (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver disease" title="Ipsen’s Kayfanda® (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver disease" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/09/17091122/PR_final.jpeg" ><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/09/17091122/PR_final.jpeg" alt="Ipsen’s Kayfanda® (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver disease" title="Ipsen’s Kayfanda® (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver disease" ></noscript> </div> </div>  <div class="p-box-text"> <button class="btn-link card-btn" style="background-color:#4e6e9a;"> Corporate </button> <span class="time-stamp">23 September 2024</span> <span class="time-stamp">8 mins read</span> <div class="text-div"> <h3>Ipsen’s Kayfanda® (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver disease</h3> </div> </div> </div> </a>  <a href="https://www.ipsen.com/press-releases/ipsens-iqirvo-elafibranor-approved-in-the-european-union-as-first-new-treatment-for-primary-biliary-cholangitis-in-nearly-a-decade-2949674/"> <div class="product-box">  <div class="p-img-container"> <div class="p-img"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" alt="Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade" title="Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/09/17091122/PR_final.jpeg" ><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/09/17091122/PR_final.jpeg" alt="Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade" title="Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade" ></noscript> </div> </div>  <div class="p-box-text"> <button class="btn-link card-btn" style="background-color:#4e6e9a;"> Corporate </button> <span class="time-stamp">20 September 2024</span> <span class="time-stamp">8 mins read</span> <div class="text-div"> <h3>Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade</h3> </div> </div> </div> </a>  <a href="https://www.ipsen.com/press-releases/final-results-from-cabinet-phase-iii-trial-reinforce-efficacy-benefits-of-cabometyx-in-advanced-neuroendocrine-tumors-2946663/"> <div class="product-box">  <div class="p-img-container"> <div class="p-img"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" alt="Final results from CABINET Phase III trial reinforce efficacy benefits of Cabometyx® in advanced neuroendocrine tumors" title="Final results from CABINET Phase III trial reinforce efficacy benefits of Cabometyx® in advanced neuroendocrine tumors" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/09/17091122/PR_final.jpeg" ><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2024/09/17091122/PR_final.jpeg" alt="Final results from CABINET Phase III trial reinforce efficacy benefits of Cabometyx® in advanced neuroendocrine tumors" title="Final results from CABINET Phase III trial reinforce efficacy benefits of Cabometyx® in advanced neuroendocrine tumors" ></noscript> </div> </div>  <div class="p-box-text"> <button class="btn-link card-btn" style="background-color:#4e6e9a;"> Corporate </button> <span class="time-stamp">16 September 2024</span> <span class="time-stamp">9 mins read</span> <div class="text-div"> <h3>Final results from CABINET Phase III trial reinforce efficacy benefits of Cabometyx® in advanced neuroendocrine tumors</h3> </div> </div> </div> </a>  <a href="https://www.ipsen.com/press-releases/ipsen-provides-update-on-contact-02-phase-iii-trial-in-metastatic-castration-resistant-prostate-cancer-following-final-overall-survival-analysis-2946293/"> <div class="product-box">  <div class="p-img-container"> <div class="p-img"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" alt="Ipsen provides update on CONTACT-02 Phase III trial in metastatic castration-resistant prostate cancer following final overall survival analysis" title="Ipsen provides update on CONTACT-02 Phase III trial in metastatic castration-resistant prostate cancer following final overall survival analysis" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" ><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" alt="Ipsen provides update on CONTACT-02 Phase III trial in metastatic castration-resistant prostate cancer following final overall survival analysis" title="Ipsen provides update on CONTACT-02 Phase III trial in metastatic castration-resistant prostate cancer following final overall survival analysis" ></noscript> </div> </div>  <div class="p-box-text"> <button class="btn-link card-btn" style="background-color:#4e6e9a;"> Corporate </button> <span class="time-stamp">15 September 2024</span> <span class="time-stamp">7 mins read</span> <div class="text-div"> <h3>Ipsen provides update on CONTACT-02 Phase III trial in metastatic castration-resistant prostate cancer following final overall survival analysis</h3> </div> </div> </div> </a>  <a href="https://www.ipsen.com/press-releases/ipsen-delivers-strong-results-in-the-first-half-of-2024-progresses-on-launches-and-upgrades-its-full-year-guidance-2918487/"> <div class="product-box">  <div class="p-img-container"> <div class="p-img"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" alt="Ipsen delivers strong results in the first half of 2024, progresses on launches and upgrades its full-year guidance" title="Ipsen delivers strong results in the first half of 2024, progresses on launches and upgrades its full-year guidance" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" ><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" alt="Ipsen delivers strong results in the first half of 2024, progresses on launches and upgrades its full-year guidance" title="Ipsen delivers strong results in the first half of 2024, progresses on launches and upgrades its full-year guidance" ></noscript> </div> </div>  <div class="p-box-text"> <button class="btn-link card-btn" style="background-color:#4e6e9a;"> Corporate </button> <span class="time-stamp">25 July 2024</span> <span class="time-stamp">7 mins read</span> <div class="text-div"> <h3>Ipsen delivers strong results in the first half of 2024, progresses on launches and upgrades its full-year guidance</h3> </div> </div> </div> </a>  <a href="https://www.ipsen.com/press-releases/ipsen-and-day-one-enter-into-exclusive-ex-u-s-licensing-agreement-to-commercialize-tovorafenib-for-the-most-common-childhood-brain-tumor-2918482/"> <div class="product-box">  <div class="p-img-container"> <div class="p-img"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" alt="Ipsen and Day One enter into exclusive ex-U.S. licensing agreement to commercialize tovorafenib for the most common childhood brain tumor" title="Ipsen and Day One enter into exclusive ex-U.S. licensing agreement to commercialize tovorafenib for the most common childhood brain tumor" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" ><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/05/28120505/PR_final.jpeg" alt="Ipsen and Day One enter into exclusive ex-U.S. licensing agreement to commercialize tovorafenib for the most common childhood brain tumor" title="Ipsen and Day One enter into exclusive ex-U.S. licensing agreement to commercialize tovorafenib for the most common childhood brain tumor" ></noscript> </div> </div>  <div class="p-box-text"> <button class="btn-link card-btn" style="background-color:#4e6e9a;"> Corporate </button> <span class="time-stamp">25 July 2024</span> <span class="time-stamp">11 mins read</span> <div class="text-div"> <h3>Ipsen and Day One enter into exclusive ex-U.S. licensing agreement to commercialize tovorafenib for the most common childhood brain tumor</h3> </div> </div> </div> </a> </div> </div> </section> </div> </div> </div> </div><section class="footer-mainbg"> <div class="container"> <footer class="mainFootContainer"> <div class="container topFoot"> <div class="row"> <div class="col-lg-3 col-md-3 col-sm-6 col-12"> <div class="stock"> <p>IPN price</p> <div class="stock-price"> <p>€110.10</p> </div> <div class="stock-per-increase"> <p><i class="bi bi-arrow-up"></i> €2.50 (2.32%)</p> </div> </div> </div> <div class="col-lg-3 col-md-3 col-sm-6 col-6"> <ul class="list-unstyled footer-menu1"> <li class="mb-2 "> <a href="https://www.ipsen.com/press-release/" target="_self" >Media</a> </li> <li class="mb-2 "> <a href="https://www.ipsen.com/investors/" target="_self" >Investors</a> </li> <li class="mb-2 "> <a href="https://www.ipsen.com/partnering/" target="_self" >Partnering</a> </li> <li class="mb-2 "> <a href="https://www.ipsen.com/careers/" target="_self" >Careers</a> </li> </ul> </div> <div class="col-lg-3 col-md-3 col-sm-6 col-6"> <ul class="list-unstyled footer-menu2"> <li class="mb-2 "> <a href="https://www.ipsen.com/company/" target="_self" >Company</a> </li> <li class="mb-2 "> <a href="https://www.ipsen.com/sustainability/" target="_self" >Sustainability</a> </li> <li class="mb-2 "> <a href="https://www.ipsen.com/patients/" target="_self" >Patients</a> </li> <li class="mb-2 "> <a href="https://www.ipsen.com/stories/" target="_self" >Stories</a> </li> </ul> </div> <div class="col-lg-3 col-md-3 col-sm-6 col-6"> <ul class="list-unstyled footer-menu3"> <li class="mb-2 external-link "> <a href="https://www.ipsen.com/annualreport/" target="_blank" >Annual Report</a> </li> <li class="mb-2 normal-link "> <a href="https://www.ipsen.com/contact-us/" target="_self" >Contact us</a> </li> </ul> </div> </div> </div> <hr>  <div class="container copyFoot"> <div class="row"> <div class="col-lg-3 col-sm-3"> <div class="mb-4"> <a href="https://www.ipsen.com/" class="custom-logo-link" rel="home"><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/12/07162335/Latest_Ipsen-logo_168x48.svg" class="custom-logo" alt="Latest_Ipsen logo" decoding="async" /></a> <div class="social-media"> <a href="https://www.linkedin.com/company/ipsen/" target="_blank"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" title="LinkedIn" alt="LinkedIn" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19050858/LinkedIn.png"><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19050858/LinkedIn.png" title="LinkedIn" alt="LinkedIn"></noscript> </a><a href="https://twitter.com/ipsengroup" target="_blank"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" title="Twitter" alt="Twitter" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/08/02083550/TWITTER_FILL_1x.png"><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/08/02083550/TWITTER_FILL_1x.png" title="Twitter" alt="Twitter"></noscript> </a><a href="https://www.facebook.com/Ipsengroup/" target="_blank"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" title="Facebook" alt="Facebook" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19053326/Facebook.png"><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19053326/Facebook.png" title="Facebook" alt="Facebook"></noscript> </a><a href="https://www.instagram.com/ipsengroup" target="_blank"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" title="Instagram" alt="Instagram" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19053437/Instagram.png"><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19053437/Instagram.png" title="Instagram" alt="Instagram"></noscript> </a><a href="https://www.youtube.com/IpsenBiopharmaceutical" target="_blank"> <img src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%200%200'%3E%3C/svg%3E" title="Youtube" alt="Youtube" data-lazy-src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19053540/Youtube-1.png"><noscript><img src="https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2023/04/19053540/Youtube-1.png" title="Youtube" alt="Youtube"></noscript> </a> </div> </div> </div> <div class="col-lg-9 col-sm-9"> <ul class="copyLinks justify-content-end"> <li class=" "><a href="https://www.ipsen.com/terms-and-conditions/" target="_self" >Terms and Conditions</a></li> <li class=" "><a href="https://www.ipsen.com/cookie-policy/" target="_self" >Cookie Policy</a></li> <li class=" "><a href="https://www.ipsen.com/global-privacy-policy/" target="_self" >Global Privacy Policy</a></li> </ul> <div class="copyright justify-content-end"> <p>Copyright © Ipsen Pharma. All rights reserved - 2024</p> </div> </div>  <a data-bg="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/images/back-to-top.jpg" class="btn-floating rocket-lazyload" id="btn-back-to-top" style=""></a> </div> </div> </div>  </footer> </div> </section>   <div class="modal" id="siteexitModal" tabindex="-1" aria-labelledby="siteexitModalLabel" aria-hidden="true"> <div class="modal-dialog modal-dialog-centered"> <div class="modal-content"> <button class="close" data-bs-dismiss="modal"> X </button> <div class="modal-body"><p>You are now leaving the Ipsen group website. To continue, please click on <b>Continue</b>?</p> </div> <div class="modal-footer"> <button type="button" class="btn btn-primary" role="button" data-bs-dismiss="modal"> <a href="#" id="continuelink" target="_blank">Continue</a> </button> <button type="button" class="btn btn-secondary" data-bs-dismiss="modal">No</button> </div> </div> </div> </div> </div>  <script> var _paq = _paq || []; _paq.push( ["setTrackingSource","wordpress","1.3.6"] ); </script> <script>document.body.classList.remove("no-js");</script><script src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/js/glider.min.js?ver=1732416125" id="carousal-glider-min-js"></script> <script data-minify="1" src="https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/dist/js/multi-select.js?ver=1732278433" id="multi-select-js"></script> <script src="https://www.ipsen.com/wp-content/themes/ipsen-main/dist/js/slick.min.js?ver=1732416125" id="slick-min-js"></script> <script data-minify="1" src="https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/dist/js/media-filter.js?ver=1732278433" id="media-filter-js"></script> <script src="https://www.ipsen.com/wp-includes/js/imagesloaded.min.js?ver=5.0.0" id="imagesloaded-js"></script> <script src="https://www.ipsen.com/wp-includes/js/masonry.min.js?ver=4.2.2" id="masonry-js"></script> <script src="https://www.ipsen.com/wp-includes/js/jquery/jquery.masonry.min.js?ver=3.1.2b" id="jquery-masonry-js"></script> <script id="wpgmp-google-map-main-js-extra"> var wpgmp_local = {"select_radius":"Select Radius","search_placeholder":"Enter address or latitude or longitude or title or city or state or country or postal code here...","select":"Select","select_all":"Select All","select_category":"Select Category","all_location":"All","show_locations":"Show Locations","sort_by":"Sort by","wpgmp_not_working":"not working...","place_icon_url":"https:\/\/www.ipsen.com\/wp-content\/plugins\/wp-google-map-gold\/assets\/images\/icons\/","wpgmp_location_no_results":"No results found.","wpgmp_route_not_avilable":"Route is not available for your requested route.","img_grid":"<span class='span_grid'><a class='wpgmp_grid'><img src='https:\/\/www.ipsen.com\/wp-content\/plugins\/wp-google-map-gold\/assets\/images\/grid.png'><\/a><\/span>","img_list":"<span class='span_list'><a class='wpgmp_list'><img src='https:\/\/www.ipsen.com\/wp-content\/plugins\/wp-google-map-gold\/assets\/images\/list.png'><\/a><\/span>","img_print":"<span class='span_print'><a class='wpgmp_print' data-action='wpgmp-print'><img src='https:\/\/www.ipsen.com\/wp-content\/plugins\/wp-google-map-gold\/assets\/images\/print.png'><\/a><\/span>","hide":"Hide","show":"Show","start_location":"Start Location","start_point":"Start Point","radius":"Radius","end_location":"End Location","take_current_location":"Take Current Location","center_location_message":"Your Location","driving":"Driving","bicycling":"Bicycling","walking":"Walking","transit":"Transit","metric":"Metric","imperial":"Imperial","find_direction":"Find Direction","miles":"Miles","km":"KM","show_amenities":"Show Amenities","find_location":"Find Locations","locate_me":"Locate Me","prev":"Prev","next":"Next","ajax_url":"https:\/\/www.ipsen.com\/wp-admin\/admin-ajax.php","nonce":"b6ba76e69e","wpgmp_country_specific":"","wpgmp_countries":"","wpgmp_assets":"https:\/\/www.ipsen.com\/wp-content\/plugins\/wp-google-map-gold\/assets\/js\/"}; </script> <script data-minify="1" src="https://www.ipsen.com/wp-content/cache/min/0/wp-content/plugins/wp-google-map-gold/assets/js/minified/maps.js?ver=1732278433" id="wpgmp-google-map-main-js"></script> <script src="https://maps.google.com/maps/api/js?key=AIzaSyBPB4Dg7WynQl-yf_SIDrPNH1Iw0FHjB-A&callback=wpgmpInitMap&libraries=geometry%2Cplaces%2Cdrawing&language=en&ver=5.7.3" id="wpgmp-google-api-js"></script> <script src="https://www.ipsen.com/wp-content/plugins/wp-google-map-gold/assets/js/minified/wpgmp_frontend.min.js?ver=5.7.3" id="wpgmp-frontend-js"></script> <script id="rocket-browser-checker-js-after"> "use strict";var _createClass=function(){function defineProperties(target,props){for(var i=0;i<props.length;i++){var descriptor=props[i];descriptor.enumerable=descriptor.enumerable||!1,descriptor.configurable=!0,"value"in descriptor&&(descriptor.writable=!0),Object.defineProperty(target,descriptor.key,descriptor)}}return function(Constructor,protoProps,staticProps){return protoProps&&defineProperties(Constructor.prototype,protoProps),staticProps&&defineProperties(Constructor,staticProps),Constructor}}();function _classCallCheck(instance,Constructor){if(!(instance instanceof Constructor))throw new TypeError("Cannot call a class as a function")}var RocketBrowserCompatibilityChecker=function(){function RocketBrowserCompatibilityChecker(options){_classCallCheck(this,RocketBrowserCompatibilityChecker),this.passiveSupported=!1,this._checkPassiveOption(this),this.options=!!this.passiveSupported&&options}return _createClass(RocketBrowserCompatibilityChecker,[{key:"_checkPassiveOption",value:function(self){try{var options={get passive(){return!(self.passiveSupported=!0)}};window.addEventListener("test",null,options),window.removeEventListener("test",null,options)}catch(err){self.passiveSupported=!1}}},{key:"initRequestIdleCallback",value:function(){!1 in window&&(window.requestIdleCallback=function(cb){var start=Date.now();return setTimeout(function(){cb({didTimeout:!1,timeRemaining:function(){return Math.max(0,50-(Date.now()-start))}})},1)}),!1 in window&&(window.cancelIdleCallback=function(id){return clearTimeout(id)})}},{key:"isDataSaverModeOn",value:function(){return"connection"in navigator&&!0===navigator.connection.saveData}},{key:"supportsLinkPrefetch",value:function(){var elem=document.createElement("link");return elem.relList&&elem.relList.supports&&elem.relList.supports("prefetch")&&window.IntersectionObserver&&"isIntersecting"in IntersectionObserverEntry.prototype}},{key:"isSlowConnection",value:function(){return"connection"in navigator&&"effectiveType"in navigator.connection&&("2g"===navigator.connection.effectiveType||"slow-2g"===navigator.connection.effectiveType)}}]),RocketBrowserCompatibilityChecker}(); </script> <script id="rocket-preload-links-js-extra"> var RocketPreloadLinksConfig = {"excludeUris":"\/(?:.+\/)?feed(?:\/(?:.+\/?)?)?$|\/(?:.+\/)?embed\/|http:\/\/(\/%5B\/%5D+)?\/(index.php\/)?(.*)wp-json(\/.*|$)|\/refer\/|\/go\/|\/recommend\/|\/recommends\/","usesTrailingSlash":"1","imageExt":"jpg|jpeg|gif|png|tiff|bmp|webp|avif|pdf|doc|docx|xls|xlsx|php","fileExt":"jpg|jpeg|gif|png|tiff|bmp|webp|avif|pdf|doc|docx|xls|xlsx|php|html|htm","siteUrl":"https:\/\/www.ipsen.com","onHoverDelay":"100","rateThrottle":"3"}; </script> <script id="rocket-preload-links-js-after"> (function() { "use strict";var r="function"==typeof Symbol&&"symbol"==typeof Symbol.iterator?function(e){return typeof e}:function(e){return e&&"function"==typeof Symbol&&e.constructor===Symbol&&e!==Symbol.prototype?"symbol":typeof e},e=function(){function i(e,t){for(var n=0;n<t.length;n++){var i=t[n];i.enumerable=i.enumerable||!1,i.configurable=!0,"value"in i&&(i.writable=!0),Object.defineProperty(e,i.key,i)}}return function(e,t,n){return t&&i(e.prototype,t),n&&i(e,n),e}}();function i(e,t){if(!(e instanceof t))throw new TypeError("Cannot call a class as a function")}var t=function(){function n(e,t){i(this,n),this.browser=e,this.config=t,this.options=this.browser.options,this.prefetched=new Set,this.eventTime=null,this.threshold=1111,this.numOnHover=0}return e(n,[{key:"init",value:function(){!this.browser.supportsLinkPrefetch()||this.browser.isDataSaverModeOn()||this.browser.isSlowConnection()||(this.regex={excludeUris:RegExp(this.config.excludeUris,"i"),images:RegExp(".("+this.config.imageExt+")$","i"),fileExt:RegExp(".("+this.config.fileExt+")$","i")},this._initListeners(this))}},{key:"_initListeners",value:function(e){-1<this.config.onHoverDelay&&document.addEventListener("mouseover",e.listener.bind(e),e.listenerOptions),document.addEventListener("mousedown",e.listener.bind(e),e.listenerOptions),document.addEventListener("touchstart",e.listener.bind(e),e.listenerOptions)}},{key:"listener",value:function(e){var t=e.target.closest("a"),n=this._prepareUrl(t);if(null!==n)switch(e.type){case"mousedown":case"touchstart":this._addPrefetchLink(n);break;case"mouseover":this._earlyPrefetch(t,n,"mouseout")}}},{key:"_earlyPrefetch",value:function(t,e,n){var i=this,r=setTimeout(function(){if(r=null,0===i.numOnHover)setTimeout(function(){return i.numOnHover=0},1e3);else if(i.numOnHover>i.config.rateThrottle)return;i.numOnHover++,i._addPrefetchLink(e)},this.config.onHoverDelay);t.addEventListener(n,function e(){t.removeEventListener(n,e,{passive:!0}),null!==r&&(clearTimeout(r),r=null)},{passive:!0})}},{key:"_addPrefetchLink",value:function(i){return this.prefetched.add(i.href),new Promise(function(e,t){var n=document.createElement("link");n.rel="prefetch",n.href=i.href,n.onload=e,n.onerror=t,document.head.appendChild(n)}).catch(function(){})}},{key:"_prepareUrl",value:function(e){if(null===e||"object"!==(void 0===e?"undefined":r(e))||!1 in e||-1===["http:","https:"].indexOf(e.protocol))return null;var t=e.href.substring(0,this.config.siteUrl.length),n=this._getPathname(e.href,t),i={original:e.href,protocol:e.protocol,origin:t,pathname:n,href:t+n};return this._isLinkOk(i)?i:null}},{key:"_getPathname",value:function(e,t){var n=t?e.substring(this.config.siteUrl.length):e;return n.startsWith("/")||(n="/"+n),this._shouldAddTrailingSlash(n)?n+"/":n}},{key:"_shouldAddTrailingSlash",value:function(e){return this.config.usesTrailingSlash&&!e.endsWith("/")&&!this.regex.fileExt.test(e)}},{key:"_isLinkOk",value:function(e){return null!==e&&"object"===(void 0===e?"undefined":r(e))&&(!this.prefetched.has(e.href)&&e.origin===this.config.siteUrl&&-1===e.href.indexOf("?")&&-1===e.href.indexOf("#")&&!this.regex.excludeUris.test(e.href)&&!this.regex.images.test(e.href))}}],[{key:"run",value:function(){"undefined"!=typeof RocketPreloadLinksConfig&&new n(new RocketBrowserCompatibilityChecker({capture:!0,passive:!0}),RocketPreloadLinksConfig).init()}}]),n}();t.run(); }()); </script> <script data-minify="1" src="https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/dist/js/custom.js?ver=1732278433" id="ipsenmain-customjs-js"></script> <script id="book-meeting-js-extra"> var ajax_var = {"url":"https:\/\/www.ipsen.com\/wp-admin\/admin-ajax.php","nonce":"4ed795bcf7"}; </script> <script data-minify="1" src="https://www.ipsen.com/wp-content/cache/min/0/wp-content/themes/ipsen-main/template-parts/ipsen-blocks/book-meeting/js/book-meeting.js?ver=1732278433" id="book-meeting-js"></script> <script src="https://www.google.com/recaptcha/api.js?ver=6.6.2" id="google-recaptcha-js"></script> <script>window.lazyLoadOptions=[{elements_selector:"img[data-lazy-src],.rocket-lazyload",data_src:"lazy-src",data_srcset:"lazy-srcset",data_sizes:"lazy-sizes",class_loading:"lazyloading",class_loaded:"lazyloaded",threshold:300,callback_loaded:function(element){if(element.tagName==="IFRAME"&&element.dataset.rocketLazyload=="fitvidscompatible"){if(element.classList.contains("lazyloaded")){if(typeof window.jQuery!="undefined"){if(jQuery.fn.fitVids){jQuery(element).parent().fitVids()}}}}}},{elements_selector:".rocket-lazyload",data_src:"lazy-src",data_srcset:"lazy-srcset",data_sizes:"lazy-sizes",class_loading:"lazyloading",class_loaded:"lazyloaded",threshold:300,}];window.addEventListener('LazyLoad::Initialized',function(e){var lazyLoadInstance=e.detail.instance;if(window.MutationObserver){var observer=new MutationObserver(function(mutations){var image_count=0;var iframe_count=0;var rocketlazy_count=0;mutations.forEach(function(mutation){for(var i=0;i<mutation.addedNodes.length;i++){if(typeof mutation.addedNodes[i].getElementsByTagName!=='function'){continue} if(typeof mutation.addedNodes[i].getElementsByClassName!=='function'){continue} images=mutation.addedNodes[i].getElementsByTagName('img');is_image=mutation.addedNodes[i].tagName=="IMG";iframes=mutation.addedNodes[i].getElementsByTagName('iframe');is_iframe=mutation.addedNodes[i].tagName=="IFRAME";rocket_lazy=mutation.addedNodes[i].getElementsByClassName('rocket-lazyload');image_count+=images.length;iframe_count+=iframes.length;rocketlazy_count+=rocket_lazy.length;if(is_image){image_count+=1} if(is_iframe){iframe_count+=1}}});if(image_count>0||iframe_count>0||rocketlazy_count>0){lazyLoadInstance.update()}});var b=document.getElementsByTagName("body")[0];var config={childList:!0,subtree:!0};observer.observe(b,config)}},!1)</script><script data-no-minify="1" async src="https://www.ipsen.com/wp-content/plugins/wp-rocket/assets/js/lazyload/17.8.3/lazyload.min.js"></script> <script type="text/javascript"> $(".wechat-container").hover(function(){ $('.icon-Wechat-qr').show(10); }, function(){ $('.icon-Wechat-qr').hide(10); }) var home_url = "https://www.ipsen.com"; jQuery(".searchDropdown").click(function(){ jQuery(".searchInput").focus(); }); jQuery(".searchDropdownMobile").click(function(){ jQuery(".searchInput").focus(); }); var searchTimeout; function show_results(val){ let list = ''; let category_name = jQuery("#cat").val(); if( category_name === '' ){ category_name = jQuery("#cat_list").val(); } let currentstore = jQuery("#currentstore").val(); if(val == "" || val.length <= 0){ jQuery(".defaultsuggestion").show(); } clearTimeout(searchTimeout); searchTimeout = setTimeout(function() { if(val.length>= 3){ searchXHR = $.ajax({ url : 'https://www.ipsen.com/wp-admin/admin-ajax.php', type : 'post', data : {lib_data_id: val, currentstore: currentstore, category_name: category_name, action:'add_to_search' }, success : function( response ) { response = jQuery.parseJSON(response); if(response.length > 0){ for (i=0; i<response.length; i++) { // list += '<li><a href="javascript:void(0);">' + response[i]['post_title'] + '</a></li>'; list += '<li><a target="_blank" href="https://www.ipsen.com/?p=' + response[i]['ID'] + '">' + response[i]['post_title'] + '</a></li>'; } //res.innerHTML = '<ul>' + list + '</ul>'; }else{ list = 'No Records Found!'; } jQuery(".defaultsuggestion").hide(); //document.getElementsByClassName("autoSuggestion").innerHTML = '<ul>' + list + '</ul>'; jQuery(".autoSuggestion").html('<ul>' + list + '</ul>'); }, complete: function () { jQuery('.loader').hide(); }, }); }else{ jQuery(".autoSuggestion").html(''); jQuery(".defaultsuggestion").show(); } }, 500); // Wait 500ms before sending the AJAX request } jQuery(".go-back-menu").click(function(){ jQuery(".dropdown-menu").removeClass("show"); }); jQuery(".go-country-back").click(function(){ jQuery(".dropdown-menu-end").removeClass("show"); jQuery(".nav-link").removeClass("show"); }); function get_download_item(){ var otp = ""; // Traverse through all inputs jQuery(".library-input").each(function(){ otp = (this.checked ? jQuery(this).val() : ""); // otp += ','; filename_download_link_ // let id = jQuery(this).val(); if( otp != ""){ // alert(otp); let downloadlink = jQuery("#download_link_"+otp).val(); console.log(otp); let fileExtension = downloadlink.substr((downloadlink.lastIndexOf('.') + 1)); console.log(downloadlink); console.log(fileExtension); let filename = jQuery("#filename_"+otp).val(); let filetype = jQuery("#filetype_"+otp).val(); let filesubtype = jQuery("#filesubtype_"+otp).val(); if (filetype != 'video'){ var link = document.createElement('a'); // link.download = 'img_pdf'+filename; // link.href = downloadlink; // document.body.appendChild(link); // link.target = "_blank"; // link.click(); // document.body.removeChild(link); // console.log(link); console.log('----------'); // console.log(filename); // link.remove(); link.setAttribute('href', downloadlink); //link.setAttribute('download', 'download.pdf'); link.setAttribute('download', 'download.'+fileExtension); link.setAttribute('target', '_blank'); document.body.appendChild(link); link.click(); document.body.removeChild(link); } if (filetype == 'video'){ var link = document.createElement('a'); link.href = downloadlink; link.download = filename + new Date() + ".mp4"; link.target = "_blank"; document.body.appendChild(link); link.click(); document.body.removeChild(link); console.log(link); console.log('----------'); console.log(filename); link.remove(); } } } ); } function get_model_item(mid){ jQuery("#loadingmodel").show(); jQuery(".media-library").show(); var filesize = jQuery("#filesize_"+mid).val(); var downloadlink = jQuery("#download_link_"+mid).val(); jQuery.ajax({ url : 'https://www.ipsen.com/wp-admin/admin-ajax.php', type : 'post', data : {lib_data_id: mid,filesize:filesize,downloadlink:downloadlink, action:'model_media'}, success : function( response ) { jQuery(".media-library").show(); jQuery("#loadingmodel").hide(); jQuery("#load_model").html(response); }, complete: function () { jQuery("#loadingmodel").hide(); }, }); } function get_load_model_item(mid){ jQuery("#loadingmodel").show(); jQuery(".media-library").show(); var filesize = jQuery("#filesize_carou_"+mid).val(); var downloadlink = jQuery("#download_link_carou_"+mid).val(); jQuery.ajax({ url : 'https://www.ipsen.com/wp-admin/admin-ajax.php', type : 'post', data : {lib_data_id: mid,filesize:filesize,downloadlink:downloadlink, action:'model_media'}, success : function( response ) { jQuery("#load_model").html(response); }, complete: function () { jQuery("#loadingmodel").hide(); }, }); } //below go-back-button click event for mobile device jQuery(".go-back-menu").click(function(){ jQuery(".nav-link.cool-link").removeClass("show"); }); function getFirstPath(url) { try { // Prepend "http://" if the protocol is missing if (!/^https?:\/\//i.test(url)) { url = 'http://' + url; } var urlObject = new URL(url); var pathname = urlObject.pathname; var pathSegments = pathname.split('/'); var firstPath = pathSegments[1]; return firstPath || null; } catch (error) { // Invalid URL or other error occurred return null; } } function addExternalLinkClass(){ // allSites = ['us','annualreport','mx','anz','de','be','nl','it','gr','japan']; var jsonString = document.getElementById('ipn-all-sites').value; var allSites = JSON.parse(jsonString); jQuery('a').filter(function() { if(this.hostname == 'wave-eu-west-1.s3.eu-west-1.amazonaws.com' || this.hostname == 'ml-eu.globenewswire.com' || this.href.includes('ml-eu.globenewswire.com') || this.href.includes('https://www.gllocation.pathnameobenewswire.com') || this.href === '#' || this.href.includes('javascript:void(0);') || this.href.startsWith('tel:') || this.href.startsWith('mailto:') || !this.hasAttribute('href') || this.href.endsWith('.pdf') || this.href.startsWith("https://www.ipsen.com/websites/ipsen_com_v2") ) { return false; } //If external site if(this.hostname !== location.hostname){ return true; } var targetUrl = this.href; var currentUrl = window.location.href; var targetFirstPath = getFirstPath(targetUrl); var currentFirstPath = getFirstPath(currentUrl); if( jQuery.inArray(currentFirstPath, allSites) !== -1 || jQuery.inArray(targetFirstPath, allSites) !== -1 ) { return targetFirstPath !== currentFirstPath } else { return false; } }).addClass("externallink"); } //below go-back-button click event for mobile device jQuery(document).on("click",".externallink", function(){ var modal = new bootstrap.Modal(document.getElementById('siteexitModal')); modal.show(); var linkurl = this.href; document.getElementById('continuelink').href = linkurl; return false; }); addExternalLinkClass(); </script> </body> </html>

CINXE.COM

Ipsen receives CHMP positive opinions for Iqirvo® (elafibranor) in Primary Biliary Cholangitis and Kayfanda® (odevixibat) in Alagille Syndrome, two rare cholestatic liver diseases