A diabetes drug, twice rejected, stumbles again — but its developer persists

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In that case // we don't need to set any segments. if (lytics_data && lytics_data.segments) { googletag.cmd.push(function() { googletag.pubads().setTargeting("LyticsSegments", lytics_data.segments); }); } }); function getUID(id) { window.dataLayer.push({'user_id': id}); }; jstag.getid(getUID); </script> <script type="text/javascript" src="/static/js/mailcheck.min.js?192616240919"></script> <script type="text/javascript" src="/static/js/dive_mailcheck.js?192616240919"></script> <script src="/static/js/app.js?040116120224"></script> <script type="text/javascript"> var divecounter_settings = {}; divecounter_settings.showSignupAd = true; </script> <script type="text/javascript" src="/static/js/divecounter.js?261616040423"></script> <script type="text/javascript"> // Special unbounce signup thing for google traffic. Test with ?test_unbounce in the URL // Note: divecounter must already be loaded. 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var trackOutboundRegisterLink = function (url) { ga('agg.send', 'event', 'event_register', url, 'Registered for event', {'hitCallback': function () { document.location = url; } }); }; // Not sure if this is being used? var trackOutboundWebsiteLink = function (url) { // No need to manually change document.location; website opens in new tab ga('agg.send', 'event', 'event_website', url, 'Visited event site'); }; </script> <script type="module" src="/static/js/dist/googleAnalyticsHelper.bundle.js?520216211124" ></script> <script type="text/javascript"> function read_cookie(cookieName) { var re = new RegExp('[; ]'+cookieName+'=([^\\s;]*)'); var sMatch = (' '+document.cookie).match(re); if (cookieName && sMatch) return unescape(sMatch[1]); return ''; } var script = document.createElement('script'); script.type = 'text/javascript'; script.async = true; script.addEventListener('load', function(e) { // we only pass the template this context variable on newsposts let informaData = false; informaData = {"canonicalUrl": "https://www.pharmavoice.com/news/lexicon-pharma-sotagliflozin-fda-adcomm-approval/732072/", "pageIsSponsored": false, "pageSponsor": "", "contentAuthor": "Amy Baxter", "contentPubDate": "2024-11-06 07:58:18", "pageID": "newspost 732072", "pageTitle": "A diabetes drug, twice rejected, stumbles again \u2014 but its developer persists", "pageType": "article", "primaryTerm": "Biotech, Pharma, Policy & Regulation, Research & Development", "secondaryTerm": "Diabetes, Drug Development"}; if (window.IIRISTracker) { var sailthru_id = read_cookie('sailthru_hid'); if (sailthru_id.length > 56) { sailthru_id = sailthru_id.slice(32,56); } var notProduction = 'False' === 'True'; var domain = 'www.pharmavoice.com'.split('.')[1]; // on non-prod environment, there is specific collector domain to send the data to. var cDomain = notProduction ? 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site_logos['bankingdive'] = { domain: 'bankingdive', site_name: "Banking Dive", alt_text: "Banking Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/banking_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/banking_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/banking_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/banking_black.svg", } }; site_logos['biopharmadive'] = { domain: 'biopharmadive', site_name: "BioPharma Dive", alt_text: "BioPharma Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/biopharma_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/biopharma_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/biopharma_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/biopharma_black.svg", } }; site_logos['cfo'] = { domain: 'cfo', site_name: "CFO.com", alt_text: "CFO.com logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/cfodotcom_white.svg", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/cfodotcom_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/cfodotcom_black.svg", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/cfodotcom_black.svg", } }; 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site_logos['educationdive'] = { domain: 'educationdive', site_name: "Education Dive", alt_text: "Education Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/education_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/education_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/education_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/education_black.svg", } }; site_logos['esgdive'] = { domain: 'esgdive', site_name: "ESG Dive", alt_text: "ESG Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/esg_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/esg_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/esg_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/esg_black.svg", } }; site_logos['facilitiesdive'] = { domain: 'facilitiesdive', site_name: "Facilities Dive", alt_text: "Facilities Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/facilities_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/facilities_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/facilities_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/facilities_black.svg", } }; site_logos['fashiondive'] = { domain: 'fashiondive', site_name: "Fashion Dive", alt_text: "Fashion Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/fashion_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/fashion_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/fashion_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/fashion_black.svg", } }; site_logos['fooddive'] = { domain: 'fooddive', site_name: "Food Dive", alt_text: "Food Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/food_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/food_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/food_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/food_black.svg", } }; site_logos['grocerydive'] = { domain: 'grocerydive', site_name: "Grocery Dive", alt_text: "Grocery Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/grocery_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/grocery_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/grocery_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/grocery_black.svg", } }; site_logos['healthcaredive'] = { domain: 'healthcaredive', site_name: "Healthcare Dive", alt_text: "Healthcare Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/healthcare_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/healthcare_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/healthcare_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/healthcare_black.svg", } }; site_logos['highereddive'] = { domain: 'highereddive', site_name: "Higher Ed Dive", alt_text: "Higher Ed Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/highered_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/highered_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/highered_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/highered_black.svg", } }; site_logos['hoteldive'] = { domain: 'hoteldive', site_name: "Hotel Dive", alt_text: "Hotel Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/hotel_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/hotel_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/hotel_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/hotel_black.svg", } }; site_logos['hrdive'] = { domain: 'hrdive', site_name: "HR Dive", alt_text: "HR Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/hr_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/hr_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/hr_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/hr_black.svg", } }; site_logos['k12dive'] = { domain: 'k12dive', site_name: "K-12 Dive", alt_text: "K-12 Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/k12_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/k12_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/k12_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/k12_black.svg", } }; site_logos['legaldive'] = { domain: 'legaldive', site_name: "Legal Dive", alt_text: "Legal Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/legal_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/legal_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/legal_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/legal_black.svg", } }; site_logos['manufacturingdive'] = { domain: 'manufacturingdive', site_name: "Manufacturing Dive", alt_text: "Manufacturing Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/manufacturing_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/manufacturing_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/manufacturing_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/manufacturing_black.svg", } }; site_logos['marketingdive'] = { domain: 'marketingdive', site_name: "Marketing Dive", alt_text: "Marketing Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/marketing_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/marketing_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/marketing_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/marketing_black.svg", } }; site_logos['medtechdive'] = { domain: 'medtechdive', site_name: "MedTech Dive", alt_text: "MedTech Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/medtech_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/medtech_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/medtech_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/medtech_black.svg", } }; site_logos['mobilemarketer'] = { domain: 'mobilemarketer', site_name: "Mobile Marketer", alt_text: "Mobile Marketer logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/mobilemarketer_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/mobilemarketer_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/mobilemarketer_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/mobilemarketer_black.svg", } }; site_logos['multifamilydive'] = { domain: 'multifamilydive', site_name: "Multifamily Dive", alt_text: "Multifamily Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/multifamily_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/multifamily_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/multifamily_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/multifamily_black.svg", } }; site_logos['packagingdive'] = { domain: 'packagingdive', site_name: "Packaging Dive", alt_text: "Packaging Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/packaging_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/packaging_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/packaging_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/packaging_black.svg", } }; site_logos['paymentsdive'] = { domain: 'paymentsdive', site_name: "Payments Dive", alt_text: "Payments Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/payments_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/payments_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/payments_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/payments_black.svg", } }; site_logos['pharmavoice'] = { domain: 'pharmavoice', site_name: "PharmaVoice", alt_text: "PharmaVoice logo", is_current_site: true, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/pharmavoice_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/pharmavoice_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/pharmavoice_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/pharmavoice_black.svg", } }; site_logos['proformative'] = { domain: 'proformative', site_name: "Proformative", alt_text: "Proformative logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/proformative_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/proformative_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/proformative_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/proformative_black.svg", } }; site_logos['restaurantdive'] = { domain: 'restaurantdive', site_name: "Restaurant Dive", alt_text: "Restaurant Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/restaurant_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/restaurant_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/restaurant_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/restaurant_black.svg", } }; site_logos['retaildive'] = { domain: 'retaildive', site_name: "Retail Dive", alt_text: "Retail Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/retail_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/retail_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/retail_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/retail_black.svg", } }; site_logos['smartcitiesdive'] = { domain: 'smartcitiesdive', site_name: "Smart Cities Dive", alt_text: "Smart Cities Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/smartcities_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/smartcities_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/smartcities_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/smartcities_black.svg", } }; site_logos['socialmediatoday'] = { domain: 'socialmediatoday', site_name: "Social Media Today", alt_text: "Social Media Today logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/smt_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/smt_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/smt_color.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/smt_color.svg", } }; site_logos['supplychaindive'] = { domain: 'supplychaindive', site_name: "Supply Chain Dive", alt_text: "Supply Chain Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/supplychain_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/supplychain_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/supplychain_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/supplychain_black.svg", } }; site_logos['truckingdive'] = { domain: 'truckingdive', site_name: "Trucking Dive", alt_text: "Trucking Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/trucking_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/trucking_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/trucking_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/trucking_black.svg", } }; site_logos['utilitydive'] = { domain: 'utilitydive', site_name: "Utility Dive", alt_text: "Utility Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/utility_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/utility_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/utility_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/utility_black.svg", } }; site_logos['wastedive'] = { domain: 'wastedive', site_name: "Waste Dive", alt_text: "Waste Dive logo", is_current_site: false, white: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/waste_white.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/waste_white.svg", }, black: { png: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/waste_black.png", svg: "https://d12v9rtnomnebu.cloudfront.net/logo/publications/waste_black.svg", } }; // Get the dive domain and return the dive logo object, or null if it doesn't exist in site_logos function getDivesiteLogoObject(link_url, alt_domain='') { let dive_domain; // Split link URL on 'adurl=' and take what comes after as the ad url const ad_url = decodeURIComponent(link_url.split('adurl=')[1]); // Split on . to get an array of hostname segments const dive_domain_array = new URL(ad_url).hostname.split('.'); // Retrieve the second to last element of the hostname array, which should always be the domain dive_domain = dive_domain_array[dive_domain_array.length - 2] if (alt_domain) { // If alt_domain has been specified, normalize it. i.e. "HR Dive", "http://hrdive.com", etc. => "hrdive" // This will override the link url's domain. dive_domain = alt_domain.replace(/\s+/g, '').replace(/^(https?:\/\/)?(www\.)?|\.com.*|\?.*|#.*/gi, '').toLowerCase(); } // Return the site logos object for this domain if it exists, or null if it does not if (site_logos[dive_domain]) { return site_logos[dive_domain]; } else { // Fallback logo const url_prefix = "https://d12v9rtnomnebu.cloudfront.net/divesite/responsive_ad_assets/small_logos/"; return { domain: 'industrydive', site_name: 'Industry Dive', alt_text: 'Industry Dive logo', white: { svg: url_prefix + 'industrydive-small-white.svg', png: url_prefix + 'industrydive-small-white.png', }, black: { svg: url_prefix + 'industrydive-small-black.svg', png: url_prefix + 'industrydive-small-black.png', } } } } eventer(messageEvent, function (e) { var key = e.message ? "message" : "data"; var data = e[key]; var eventName = data.message || 'ignore'; if (eventName == 'adContentAvailable') { var $ad_element; $ad_element = $('div').filter('[data-container-ad-unit-id="' + data.adUnit + '-' + window.dfp_visibility + '"]'); $ad_element.hide() var nativeAdEditorialSelector = '.sidebar .hybrid-ad-wrapper .native-ad-editorial'; var nativeAdEditorialExists = $(nativeAdEditorialSelector).length > 0; if ( nativeAdEditorialExists ) { $(nativeAdEditorialSelector).closest('.hybrid-ad-wrapper').addClass('native-ad-editorial-sidebar-border'); } // Inline homepage ad $('.feed-item-ad .hybrid-ad-wrapper a').each(function (index, element) { window.updateGamAdUrl(element, 'inline'); }); // Editorial native ad sidebar // NOTE: must go before inline native ad to ensure correct location added $('.sidebar .native-ad.editorial a').each(function (index, element) { window.updateGamAdUrl(element, 'sidebar'); }); // Editorial native ad inline $('.native-ad.editorial a').each(function (index, element) { window.updateGamAdUrl(element, 'inline'); }); // Sidebar ad $('.sidebar .hybrid-ad-wrapper a').each(function (index, element) { window.updateGamAdUrl(element, 'sidebar'); }); } }, false); var googletag = googletag || {}; googletag.cmd = googletag.cmd || []; googletag.cmd.push(function () { var desktopWidth = 1024; if (window.innerWidth >= desktopWidth) { window.dfp_visibility = 'desktop'; } else { window.dfp_visibility = 'mobile'; } var dfpDisplayConfiguration = { "prestitialEnabled": true, "leaderboardEnabled": true, "sidebarAdsEnabled": true, "visibility": window.dfp_visibility }; if (window.dfp_visibility == 'desktop') { if (typeof prestitialAds == 'object' && prestitialAds.pageIsPrestitialEligible()) { googletag.defineSlot('/21662595662/pharmavoice/pharmavoiceprestitial', [[500, 300], [640, 480]], 'paychekgoeshere').addService(googletag.pubads()); } if (dfpDisplayConfiguration.leaderboardEnabled) { googletag.defineSlot('/21662595662/pharmavoice/pharmavoiceleaderboard', [[970, 180], [728, 90], [970, 90]], 'dfp-leaderboard-desktop').addService(googletag.pubads()); googletag.pubads().addEventListener('slotRenderEnded', function (event) { if ((event.slot.getAdUnitPath() === '/21662595662/pharmavoice/pharmavoiceleaderboard' || event.slot.getAdUnitPath() === '/21662595662/pharmavoice/pharmavoiceleaderboard') && !event.isEmpty ) { $(window).blur(function () { if (document.activeElement === $('#dfp-leaderboard-desktop iframe')[0] || document.activeElement === $('#dfp-leaderboard-desktop iframe')[0]) { try { localStorage.setItem('leaderboard_signup_path', document.location.pathname); } catch (e) { // local storage could not be available due to privacy settings or something } } }); } }); } if (dfpDisplayConfiguration.sidebarAdsEnabled) { googletag.defineSlot('/21662595662/pharmavoice/pharmavoicehybrid1', [[300, 250], 'fluid', [160, 600]], 'dfp-hybrid1-desktop').addService(googletag.pubads()); } googletag.defineSlot('/21662595662/pharmavoice/pharmavoicehybrid2', [[300, 250], 'fluid'], 'dfp-hybrid2-desktop').addService(googletag.pubads()); googletag.defineSlot('/21662595662/pharmavoice/pharmavoicehybrid3', [[300, 250], 'fluid'], 'dfp-hybrid3-desktop').addService(googletag.pubads()); googletag.defineSlot('/21662595662/pharmavoice/pharmavoicehybrid4', [[300, 250], 'fluid'], 'dfp-hybrid4-desktop').addService(googletag.pubads()); googletag.defineSlot('/21662595662/pharmavoice/pharmavoicethankyouhybrid1', ['fluid'], 'dfp-thankyouhybrid1-desktop').addService(googletag.pubads()); googletag.defineSlot('/21662595662/pharmavoice/pharmavoicethankyouhybrid2', ['fluid'], 'dfp-thankyouhybrid2-desktop').addService(googletag.pubads()); } else { googletag.defineSlot('/21662595662/pharmavoice/pharmavoicehybrid1', [[300, 250], 'fluid'], 'dfp-hybrid1-mobile').addService(googletag.pubads()); googletag.defineSlot('/21662595662/pharmavoice/pharmavoicehybrid2', [[300, 250], 'fluid'], 'dfp-hybrid2-mobile').addService(googletag.pubads()); googletag.defineSlot('/21662595662/pharmavoice/pharmavoicehybrid3', [[300, 250], 'fluid'], 'dfp-hybrid3-mobile').addService(googletag.pubads()); googletag.defineSlot('/21662595662/pharmavoice/pharmavoicehybrid4', [[300, 250], 'fluid'], 'dfp-hybrid4-mobile').addService(googletag.pubads()); googletag.defineSlot('/21662595662/pharmavoice/pharmavoicethankyouhybrid1', ['fluid'], 'dfp-thankyouhybrid1-mobile').addService(googletag.pubads()); googletag.defineSlot('/21662595662/pharmavoice/pharmavoicethankyouhybrid2', ['fluid'], 'dfp-thankyouhybrid2-mobile').addService(googletag.pubads()); } googletag.pubads().setTargeting("topics", ["Biotech","biotech","Pharma","pharma","Policy & Regulation","policy-regulation","Research & Development","research-development"]); googletag.pubads().setTargeting("tags", ["pharmavoice-tag-diabetes","pharmavoice-tag-drug-development"]); if ((typeof divecounter !== "undefined") && (divecounter.getData().is_subscriber)) { googletag.pubads().setTargeting("is_subscriber", "yes"); } var site = window.location.host; googletag.pubads().setTargeting("site", site); var first_path = window.location.pathname.split( '/' )[1]; googletag.pubads().setTargeting("first_path", first_path); googletag.pubads().setTargeting("newspost_type", "Article"); googletag.pubads().setTargeting("articleID", "732072"); 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100vw" alt=""> <article class=""> <div class="first-page-pdf">  <div class="printed-branding"> <span class="promoted-branded-copy">An article from</span> <img src="https://d12v9rtnomnebu.cloudfront.net/logo/printer_friendly/pharmavoice.jpg" alt="site logo"> </div> <div class="article-title-wrapper"> <div class="post-label-wrapper"> </div> <h1 class="display-heading-04"> A diabetes drug, twice rejected, stumbles again — but its developer persists </h1> <p>After multiple rejections, Lexicon Pharmaceuticals is inching toward an FDA decision date next month for its adjunct type 1 diabetes therapy.</p> </div> <div class="byline"> <div class="article-byline"> <div class="date date-bottom-border"> <span class="published-info"> Published Nov. 6, 2024 </span> </div> <div class="byline-row "> <div class="author "> <div class="author-row author-row-flex"> <a href="/editors/abaxter/"> <img class="author-img-round analytics t-article-byline-author" 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Please let us know if you have <a href="/contact/">feedback</a>. </div> </div> </div> <p>Not all drugs have an easy path to market, and an FDA rejection can hit hard. For Lexicon Pharmaceuticals, the hits keep coming, in the form of two rejections and a disappointing adcomm for its type 1 diabetes and chronic kidney disease candidate sotagliflozin.</p> <p>The FDA first <a href="https://www.biopharmadive.com/news/fda-knocks-back-diabetes-drug-from-sanofi-lexicon/551134/">rejected sotagliflozin</a> for type 1 diabetes patients in 2019, when Lexicon was partnered with Sanofi on the drug. The pharma giant subsequently ducked out of the partnership via a <a href="https://www.biopharmadive.com/news/sanofi-lexicon-settlement-zynquista-exit-diabetes-partnership/562705/">$260 million payment</a> to Lexicon. Then, the biotech lost <a href="https://www.biopharmadive.com/news/fda-deny-lexicon-appeal-zynquista-diabetes-drug-rejection/568255/">a bid for an appeal</a> the following year, but still the company continued to develop sotagliflozin, which was approved in the EU for as an adjunct treatment to insulin in type 1 diabetes and launched with the brand name Zynquista. </p> <div class="hybrid-ad-wrapper show-small hide-large"> <div class="hybrid-ad-inner-wrapper"> <div class="show-small hide-large"> <div data-container-ad-unit-id="/21662595662/pharmavoice/pharmavoicehybrid1-mobile"></div> <div id="dfp-hybrid1-mobile"> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script> waitToLoadAds.push(function() { googletag.cmd.push(function() { if (window.dfp_visibility == 'mobile' ) { googletag.display('dfp-hybrid1-mobile'); googletag.pubads().addEventListener('slotRenderEnded', function (event) { var adUnitPath = '/21662595662/pharmavoice/pharmavoicehybrid1'; var onProformative = false; if (onProformative && event.slot.getAdUnitPath() === adUnitPath && !event.isEmpty ) { var adUnitPathWithVisibility = adUnitPath + '-mobile'; var selector = '.pf-comments__ad-wrapper [data-container-ad-unit-id="' + adUnitPathWithVisibility + '"]'; if (!$(selector).closest('.pf-comments__ad-wrapper').hasClass('borders')) { $(selector).closest('.pf-comments__ad-wrapper').addClass('borders') } } }); } }); }); </script> </div> </div> </div> </div> <div class="hybrid-ad-wrapper hide-small show-large"> <div class="hybrid-ad-inner-wrapper"> <div class="hide-small show-large"> <div data-container-ad-unit-id="/21662595662/pharmavoice/pharmavoicehybrid2-desktop"></div> <div id="dfp-hybrid2-desktop"> <script> waitToLoadAds.push(function() { googletag.cmd.push(function() { if (window.dfp_visibility == 'desktop' ) { googletag.display('dfp-hybrid2-desktop'); googletag.pubads().addEventListener('slotRenderEnded', function (event) { var adUnitPath = '/21662595662/pharmavoice/pharmavoicehybrid2'; var onProformative = false; if (onProformative && event.slot.getAdUnitPath() === adUnitPath && !event.isEmpty ) { var adUnitPathWithVisibility = adUnitPath + '-desktop'; var selector = '.pf-comments__ad-wrapper [data-container-ad-unit-id="' + adUnitPathWithVisibility + '"]'; if (!$(selector).closest('.pf-comments__ad-wrapper').hasClass('borders')) { $(selector).closest('.pf-comments__ad-wrapper').addClass('borders') } } }); } }); }); </script> </div> </div> </div> </div> <p>But Lexicon’s ongoing bid to expand into the U.S. type 1 diabetes market was dealt a third blow last week when an advisory committee voted against the drug for approval. While the adcomm’s decision is non-binding, the agency was <a href="https://jamanetwork.com/journals/jama-health-forum/fullarticle/2807050#:~:text=Findings%20In%20this%20qualitative%20study,supplemental%20approvals%2C%20and%20safety%20actions.">in agreement 88% of the time</a> between 2010 and 2021, and the result highlights a lack of faith in the beleaguered drug. Lexicon CEO Mike Exton found a silver lining when <a href="https://www.youtube.com/live/dg258G9QbXQ">committee experts agreed</a> there was an urgent need for this patient group, but they ultimately decided there was not enough data to prove the drug’s benefits outweighed the risks.</p> <p>“We are disappointed in the outcome of today’s advisory committee vote,” Exton said in a statement. “However, we were encouraged by the rich discussion and outpouring of support across the diabetes community in favor of sotagliflozin being made available to appropriate people with [type 1 diabetes] and [chronic kidney disease].”</p> <h3 class="standard-heading">Market opportunities</h3> <p>The company announced earlier this year that it was <a href="https://www.lexpharma.com/media-center/news/2024-08-13-lexicon-pharmaceuticals-announces-strategic-repositioning-to-drive-value-and-growth-of-commercial-portfolio">cutting about half of its “field force</a>” as part of a $40 million cost-saving effort to prepare for the drug’s launch. </p> <p>It’s a tough pill to swallow with a market opportunity upwards of $400 million for the patient group, according to <a href="https://www.biopharmadive.com/news/lexicon-viatris-sotagliflozin-license-deal-ex-us-rights/730154/">some estimates</a>. Other estimates had projected sotagliflozin could reach <a href="http://sotagliflozin">$1 billion in sales</a>. </p> <p>Lexicon maintains that sotagliflozin would be the only adjunct therapy to insulin for patients with type 2 diabetes and chronic kidney disease if approved. The patient need is also high, as <a href="https://www.lexpharma.com/media-center/news/2024-10-31-lexicon-announces-outcome-of-fda-advisory-committee-for-zynquista-sotagliflozin-as-an-adjunct-to-insulin-therapy-for-glycemic-control-in-adults-with-type-1-diabetes-and-chronic-kidney-disease">only 20%</a> of type 1 diabetes patients can maintain adequate glycemic control with just insulin, Dr. Steve Edelman, professor of medicine at the University of California, San Diego, and founder and director of Taking Control Of Your Diabetes, said in Lexicon’s Oct. 31 release.</p> <div class="hybrid-ad-wrapper show-small hide-large"> <div class="hybrid-ad-inner-wrapper"> <div class="show-small hide-large"> <div data-container-ad-unit-id="/21662595662/pharmavoice/pharmavoicehybrid2-mobile"></div> <div id="dfp-hybrid2-mobile"> <script> waitToLoadAds.push(function() { googletag.cmd.push(function() { if (window.dfp_visibility == 'mobile' ) { googletag.display('dfp-hybrid2-mobile'); googletag.pubads().addEventListener('slotRenderEnded', function (event) { var adUnitPath = '/21662595662/pharmavoice/pharmavoicehybrid2'; var onProformative = false; if (onProformative && event.slot.getAdUnitPath() === adUnitPath && !event.isEmpty ) { var adUnitPathWithVisibility = adUnitPath + '-mobile'; var selector = '.pf-comments__ad-wrapper [data-container-ad-unit-id="' + adUnitPathWithVisibility + '"]'; if (!$(selector).closest('.pf-comments__ad-wrapper').hasClass('borders')) { $(selector).closest('.pf-comments__ad-wrapper').addClass('borders') } } }); } }); }); </script> </div> </div> </div> </div> <div class="hide-small show-large" id="desktop-inline-signup"></div> <p>Zynquista is an oral SGLT1/SGLT2 inhibitor that already has legs in other indications. But after its EU approval, its marketing authorization was <a href="https://www.ema.europa.eu/en/medicines/human/EPAR/zynquista">withdrawn in 2022</a> after Guidehouse Germany, which held the marketing rights, decided not to market the drug.</p> <p>When the FDA rejected Zynquista in 2019, advisory committee members were split, voting 8-8. This time, with an 11-3 vote, Lexicon’s path to the finish line in type 1 diabetes is even rockier. </p> <p>The company expects the FDA to render a decision on Dec. 20.</p> <h3 class="standard-heading">Heart failure hopes</h3> <p>Lexicon last year secured an FDA approval in heart failure for sotagliflozin, sold under the brand name Inpefa for the indication, as well as for some type 2 diabetes patients with cardiovascular risks. Inpefa is the company’s only approved drug on the U.S. market, but it has yet to pick up sales traction. During the second quarter of 2024, Lexicon reported <a href="https://www.lexpharma.com/media-center/news/2024-08-01-lexicon-pharmaceuticals-reports-second-quarter-2024-financial-results-and-provides-business-update">$1.6 million in sales</a> and $1.1 million in the first three months of the year.</p> <p>There’s likely some upside on the way. Last month, Lexicon penned a <a href="https://www.biopharmadive.com/news/lexicon-viatris-sotagliflozin-license-deal-ex-us-rights/730154/">$25 million deal</a> with generics giant Viatris for the rights to sell Inpefa outside the U.S. and Europe, with Lexicon retaining some royalty rights. The company is still far from reaching <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-lexicon-pharmas-heart-failure-drug-2023-05-26/">projected sales</a> of $112 million by 2025 and $576 million by 2028, Reuters reported last year.</p> <p>Lexicon’s Inpefa is also facing Big Pharma competition. Boehringer Ingelheim and Eli Lilly’s Jardiance is also an SGLT2 inhibitor approved for reducing cardiovascular risk in type 2 diabetes patients, as well as heart failure and chronic kidney disease — the same indications where Lexicon is looking to make headway. Jardiance has been a smash success, raking in <a href="https://www.boehringer-ingelheim.com/us/boehringer-ingelheim-reports-strong-growth-2023-and-accelerates-late-stage-pipeline#:~:text=Human%20Pharma%20portfolio%20shows%20strong,billion%20(EUR%207.4%20billion).">$8 billion in sales</a> in 2023, Boehringer Ingelheim reported. And the drug is so widely used it landed on the first 10 drugs in Medicare’s newly established <a href="https://www.pharmavoice.com/news/pharma-execs-drug-price-negotiations-IRA/723791/">drug price negotiation program</a>, which will take effect in 2026.</p><div class="show-small hide-large" id="mobile-inline-signup"></div><section class="storylines-carousel-wrapper hide-small show-large" id="desktop-carousel"></section> <p>Beyond type 1 diabetes, the company is <a href="https://www.lexpharma.com/static/5c036a0bff6644de016ab245a0408962/corporate-presentation.pdf">undertaking phase 3 testing</a> for a hypertrophic cardiomyopathy indication for sotagliflozin. Elsewhere in the pipeline, Lexicon has a phase 2 candidate for diabetic peripheral neuropathic pain and a preclinical obesity asset.</p> </div> <div class="reading-list recommended-reading"> <h3 class="sidebar-box__header reading-list__header">Recommended Reading</h3> <ul class="list-no-bullets"> <li class="reading-list__item"> <a href="https://www.pharmavoice.com/news/fda-adcomm-reform-talks-heat-up/725817/" target="_blank" class="reading-list__link analytics t-article-end-recommended"> FDA adcomm reform talks heat up </a> <span class="label label--soft"> <img src="/static/img/offsite_black.png?102717100918" class="off-site-link" alt="offsite link" width="12" height="12" /> <span>Amy Baxter</span> </span> </li> <li class="reading-list__item"> <a href="https://www.pharmavoice.com/news/fda-adcomm-als-nurown-intacia-cold-medicine/695116/" target="_blank" class="reading-list__link analytics t-article-end-recommended"> 3 recent FDA adcomm rejections — and why they matter </a> <span 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A diabetes drug, twice rejected, stumbles again — but its developer persists | PharmaVoice