FDA panel does not favor expanded indications for Vascepa

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The panel voted 9-2 against widening the indications based on results of the ANCHOR trial. Panel members said the available data show that icosapent ethyl (Vascepa, Amarin) reduces triglycerides, but do not convincingly "/><meta id="metaKeywords" name="keywords" content="Cardiology,Cardiology,Endocrinology,CHD/Prevention,Cardiometabolic Disorders,FDA advisory panel decisions"/><meta id="Meta1" name="scID"/><meta id="scID" name="scID"/><meta name="PostedDate" content="2013-10-16"/> <meta name="ModifiedDate" content="2013-10-16"/> <meta name="specialties" content="Cardiology,Endocrinology"/> <meta name="specialty" content="Cardiology"/> <meta name="specialty" content="Endocrinology"/> <meta name="primary_specialty" content="Cardiology"/> <meta name="subspecialties" content="CHD/Prevention,Cardiometabolic Disorders"/> <meta name="subspecialty" content="CHD/Prevention"/> <meta name="subspecialty" content="Cardiometabolic Disorders"/> <meta name="primary_subspecialty" content="CHD/Prevention"/> <meta name="departments" content="FDA advisory panel decisions"/> <meta name="department" content="FDA advisory panel decisions"/> <meta name="content_type" content="News Article"/> <meta name="pageid" content="{4B497C6F-12E1-4A94-BF66-E04D6B6741FD}"/> <meta property="og:image" content="https://web.archive.org/web/20131024064548im_/http://213a1ca8842e5e699a80-05ce35571e92a3f7383a191aa5840bba.r66.cf1.rackcdn.com/healio_safe_image.png"/><meta name="authors" content=""/><meta name="articleid" content="{4B497C6F-12E1-4A94-BF66-E04D6B6741FD}"/><meta name="legacyarticleid" content=""/><meta name="article-title" content="FDA panel does not favor expanded indications for Vascepa"/><meta name="article-link" content="/cardiology/chd-prevention/news/online/{4b497c6f-12e1-4a94-bf66-e04d6b6741fd}/fda-panel-does-not-favor-expanded-indications-for-vascepa"/><meta name="pubname" content="Cardiology"/><meta name="pubtype" content="online"/><meta name="issue-name" content="16"/><meta name="issue-year" content=""/><meta name="source" content=""/><meta name="author" content=""/>  <link href="https://web.archive.org/web/20131024064548cs_/http://c341130.r30.cf1.rackcdn.com/styles.css" rel="stylesheet" type="text/css"/>  <link href="https://web.archive.org/web/20131024064548cs_/http://c341130.r30.cf1.rackcdn.com/styles2.css" rel="stylesheet" type="text/css"/><link href="https://web.archive.org/web/20131024064548cs_/http://c341130.r30.cf1.rackcdn.com/tb-ec-lb-min.css" rel="stylesheet" type="text/css" media="screen"/><link href="https://web.archive.org/web/20131024064548cs_/http://0043b493b06d545127da-d7c71b4c9ba1dd44e0cf6fa474e637d7.r99.cf1.rackcdn.com/healiojobs.css" rel="stylesheet" type="text/css"/><link href="https://web.archive.org/web/20131024064548cs_/http://6af4390358a281e0b439-028b17272c3ee5c2953a93a8c54187e2.r22.cf1.rackcdn.com/MediaKits.css" rel="stylesheet" type="text/css"/>  <link rel="shortcut icon" type="image/x-icon" href="https://web.archive.org/web/20131024064548im_/http://213a1ca8842e5e699a80-05ce35571e92a3f7383a191aa5840bba.r66.cf1.rackcdn.com/favicon.ico"/> <style type="text/css"> #wrap:before, #wrap:after { content: " "; display: table; } #wrap:after { clear: both; } </style> <script type="text/javascript" language="javascript" src="https://web.archive.org/web/20131024064548js_/http://ajax.googleapis.com/ajax/libs/jquery/1.8.2/jquery.min.js"></script> <script type="text/javascript" language="javascript" src="https://web.archive.org/web/20131024064548js_/http://cdn.jquerytools.org/1.2.7/full/jquery.tools.min.js"></script> <script type="text/javascript" language="javascript">$j = $.noConflict();</script> <script type="text/javascript" language="javascript" src="https://web.archive.org/web/20131024064548js_/http://c341136.r36.cf1.rackcdn.com/thickbox-compressed.js"></script> <script type="text/javascript">var globalUserID = 0;</script>  <script type="text/javascript" charset="utf-8"> var pd_tags = new Array; if (globalUserID !== undefined || globalUserID !== null) { pd_tags['customer_ID'] = globalUserID; } </script> <script type="text/javascript" charset="utf-8" src="https://web.archive.org/web/20131024064548js_/http://static.polldaddy.com/p/3191508.js"></script> <script type="text/javascript"> var googletag = googletag || {}; googletag.cmd = googletag.cmd || []; (function() { var gads = document.createElement('script'); gads.async = true; gads.type = 'text/javascript'; var useSSL = 'https:' == document.location.protocol; gads.src = (useSSL ? 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QhNVkhlYWRlcg8PZGZkr7JbHlZ8o5aK16lLXZ1HAz0+rMiwisAA7luZfH3/oq0="/> 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href="/web/20131024064548/http://www.healio.com/cardiology/chd-prevention"> CHD/Prevention</a> <span>›</span> <a href="/web/20131024064548/http://www.healio.com/cardiology/chd-prevention/news"> News</a> </p>   <div id="SeeAlso" class="related-links"><h3>See Also</h3><ul><li><a href="https://web.archive.org/web/20131024064548/http://www.healio.com/cardiology/chd-prevention/news/online/%7B2650ddb8-44df-48c4-ac42-74175ab3db9a%7D/fda-advisory-panel-votes-in-favor-of-lomitapide">FDA advisory panel votes in favor of lomitapide</a></li><li><a href="https://web.archive.org/web/20131024064548/http://www.healio.com/cardiology/chd-prevention/news/online/%7Bdb0b2b4f-bee6-4e27-8e68-249b85c348c2%7D/juxtapid-earns-fda-approval-in-homozygous-familial-hypercholesterolemia">Juxtapid earns FDA approval in homozygous familial ...</a></li><li><a href="https://web.archive.org/web/20131024064548/http://www.healio.com/cardiology/chd-prevention/news/online/%7Ba229ed2f-d3b6-4d68-848f-2db815a51260%7D/azithromycin-not-associated-with-cvd-mortality-in-general-population">Azithromycin not associated with CVD mortality in general ...</a></li></ul></div> <input name="layout_0$maincontent_0$seeAlsoInsertUnderParagraph" type="hidden" id="layout_0_maincontent_0_seeAlsoInsertUnderParagraph" value="1"/>  <div class="content"> <h2> FDA panel does not favor expanded indications for Vascepa</h2> <h3 class="deck"> </h3> <p class="main-subtitle"> </p> <div class="social-links-top"> <ul class="share"> <li class="l1"><a href="javascript:void(0)" class="facebook-link" target="_new">Facebook</a></li> <li class="l2"><a href="javascript:void(0)" class="twitter-link" target="_new">Tweet</a></li> <li class="l3"><a href="javascript:void(0)" class="linkedin-link">Share</a></li> </ul> </div> <ul class="meta-info"> <li> October 16, 2013</li> </ul> <div class="wyContent"> <p class="BodyCxSpFirst">The FDA Endocrinologic and Metabolic Drugs Advisory Committee today voted against expanding indications for icosapent ethyl to include a wider patient population at this time.</p> <p class="BodyCxSpMiddle">The panel voted 9-2 against widening the indications based on results of the ANCHOR trial. Panel members said the available data show that icosapent ethyl (Vascepa, Amarin) reduces triglycerides, but do not convincingly demonstrate that it reduces CV risk. The committee said it awaits the results of the REDUCE-IT study, which will evaluate icosapent ethyl for the reduction of CV events in patients with hypertriglyceridemia who are taking a statin.</p> <p class="BodyCxSpMiddle"><strong>Clinical benefit uncertain</strong></p> <p class="BodyCxSpMiddle">“The [CV] outcome benefit is uncertain based on the data presented,” committee chairman <strong>Robert J. Smith, MD,</strong> said when summarizing panel feedback to FDA staff.</p> <p class="BodyCxSpMiddle">Vascepa is an omega-3 fatty acid that was approved in July 2012 for the reduction of triglycerides in adults with severe hypertriglyceridemia. Amarin has applied for another indication for the drug, used in conjunction with a statin, to reduce triglycerides, non-HDL, apolipoprotein B, LDL, total cholesterol and very low density lipoprotein in adults with mixed dyslipidemia and CHD or a CHD risk equivalent.</p> <p class="BodyCxSpMiddle">The data on Vascepa in this patient population come from the <a href="https://web.archive.org/web/20131024064548/http://www.healio.com/cardiology/chd-prevention/news/online/%7Bb4b30f7a-a556-415c-b32b-396dc3cd234f%7D/omega-3-fatty-acid-yielded-significant-reductions-in-triglycerides" target="_blank">ANCHOR trial</a>, which tested the efficacy of icosapent ethyl for the reduction of high triglycerides without increasing LDL in 702 participants on statin background therapy. Those assigned 4 g Vascepa per day had a 21.5% decrease in triglycerides (<em>P</em><.0001) and those assigned 2 g Vascepa per day had a 10.1% reduction in triglycerides (<em>P</em>=.0005) compared with those assigned mineral oil placebo. </p> <p class="BodyCxSpMiddle">However, while the ANCHOR trial data showed that participants assigned Vascepa received a benefit in terms of triglyceride levels and other lipid and lipoprotein indicators, it was not designed to demonstrate improved CV outcomes, and panel members said they were not willing to assume that improved lipid parameters would lead to improved CV outcomes. </p> <p class="BodyCxSpMiddle">“I’m not sure that we need more agents prescribed because we think maybe they’re going to work,” said panel member <strong>Peter W.F. Wilson, MD</strong>. “We should rely on what we know that works.” </p> <p class="BodyCxSpMiddle"><strong>Failed trials of other agents hurt cause</strong></p> <p class="BodyCxSpMiddle">FDA staff and panel members said a factor working against expanding indications for Vascepa at this time is that between approval of the ANCHOR study design and now, other trials such as ACCORD, AIM-HIGH and HPS2-THRIVE produced results showing that agents added to statin therapy did not improve CV outcomes despite improving various lipid indicators. </p> <p class="BodyCxSpMiddle">“The scientific landscape has shifted dramatically in the last 4 to 5 years,” said panel member <strong>Brendan M. Everett, MD, MPH</strong>. “While I am optimistic that there could be substantial benefit for patients with CHD, I am wary of approving [an agent] without hard efficacy data.”</p> <p class="BodyCxSpMiddle">FDA staff and panel members also expressed concern about the mineral oil placebo used in ANCHOR. According to an FDA briefing document, the results “at least suggest the possibility that mineral oil may not be biologically inert” because “within-group changes in lipid parameters and biomarkers of inflammation from baseline to 12 weeks were highly statistically significant in the mineral oil placebo group (all <em>P</em><.001).” It may not be clear whether the treatment effect was a result of icosapent ethyl lowering LDL or mineral oil raising LDL, according to the document. </p> <p class="BodyCxSpMiddle">The FDA is not required to follow the recommendations of its advisory panels, but it usually does. – <em>by Erik Swain</em></p> <p class="BodyCxSpMiddle"><strong>For more information:</strong></p> <p class="BodyCxSpLast"><a href="https://web.archive.org/web/20131024064548/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM370985.pdf" target="_blank">EMDAC Clinical Briefing Document. sNDA 202057/S-005</a>.</p> </div>  <div class="fig left"> <p class="figcaption"> </p> </div> <div class="wyPagination">   </div>  <div class="follow"> <img src="/web/20131024064548im_/http://www.healio.com/~/media/Images/News/FollowUs.jpg" id="layout_0_maincontent_1_SocialFollow_socialfollow" name="socialfollow" alt="Follow us" usemap="#followus" border="0"/> <map id="followus" name="followus"> <area id="layout_0_maincontent_1_SocialFollow_followfb" shape="rect" coords="51,5,5,51" target="_blank" href="https://web.archive.org/web/20131024064548/http://www.facebook.com/cardiologytoday" alt="Follow us on Facebook"></area> <area id="layout_0_maincontent_1_SocialFollow_followtw" shape="rect" coords="270,3,320,50" target="_blank" href="https://web.archive.org/web/20131024064548/http://www.twitter.com/cardiologytoday" alt="Follow us on Twitter"></area> </map> </div> </div>  <div class="social-links"> <div class="fb-like" data-send="false" data-width="300" data-show-faces="true" data-action="recommend"></div> <ul class="share"> <li><a href="javascript:void(0)" id="twitter" class="twitter-link" target="_new">Tweet</a></li> <li><a href="javascript:void(0)" id="facebook" class="facebook-link" target="_new">Share</a></li> <li class="linkedin"><a href="javascript:void(0)" id="linkedin" class="linkedin-link">Link</a></li> <li><span class="db-wrapper"><span class="g-plusone" data-size="tall" data-annotation="none"></span></span></li> <li><a href="javascript:void(0)" id="email">Email</a></li> <li class="last"><a href="javascript:void(0)" id="print">Print</a></li> </ul> <input name="layout_0$maincontent_1$SocialMedia$articleItemForTweet" type="hidden" id="layout_0_maincontent_1_SocialMedia_articleItemForTweet" value="{4B497C6F-12E1-4A94-BF66-E04D6B6741FD}"/> <input name="layout_0$maincontent_1$SocialMedia$tweettext" type="hidden" id="layout_0_maincontent_1_SocialMedia_tweettext" class="tweettext" value="FDA panel does not favor expanded indications for Vascepa "/> <input name="layout_0$maincontent_1$SocialMedia$tweeturl" type="hidden" id="layout_0_maincontent_1_SocialMedia_tweeturl" class="tweeturl" value="http://goo.gl/xN9ZzH"/> </div>  <div id="respond"> <h4> Comments</h4> <script language="javascript" type="text/javascript"> var idcomments_acct = 'aa6ff53f9870e40f92f83e1b5df3cddf'; var idcomments_post_id = '{4B497C6F-12E1-4A94-BF66-E04D6B6741FD}'; var idcomments_post_url; </script> <span id="IDCommentsPostTitle" style="display: none"></span> <script type="text/javascript" src="https://web.archive.org/web/20131024064548js_/http://www.intensedebate.com/js/genericCommentWrapperV2.js"></script> <p class="comment-notes"> Healio is intended for health care provider use and all comments will be posted at the discretion of the editors. 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FDA panel does not favor expanded indications for Vascepa | Cardiology