{"id":29264,"date":"2012-05-23T18:25:19","date_gmt":"2012-05-23T22:25:19","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=29264"},"modified":"2012-05-23T18:25:19","modified_gmt":"2012-05-23T22:25:19","slug":"fda-advisory-committee-recommends-against-acs-indication-for-rivaroxaban","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/05\/23\/fda-advisory-committee-recommends-against-acs-indication-for-rivaroxaban\/","title":{"rendered":"FDA Advisory Committee Recommends Against ACS Indication for Rivaroxaban"},"content":{"rendered":"<p>The FDA&#8217;s\u00a0Cardiovascular and Renal Drugs Advisory Committee voted today against adding an indication for acute coronary syndromes (ACS) to the label of the anticoagulant rivaroxaban (Xarelto). The vote was 6 to 4 against approval, with 1 abstention.<\/p>\n<p>The advisory panel spent most of the day trying to reconcile diametrically opposed views of the\u00a0<a title=\"ATLAS ACS 2-TIMI 51: Rivaroxaban Beneficial in Low-Risk ACS\u00a0Population\" href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1112277\">pivotal ATLAS ACS 2-TIMI 51 trial<\/a>. On the one hand,\u00a0the sponsor (Johnson &amp; Johnson) and the TIMI investigators (Jessica Mega, C. Michael Gibson, and\u00a0Eugene\u00a0Braunwald) portrayed a robustly positive trial that strongly demonstrated the beneficial effects of low-dose rivaroxaban in ACS when added to dual antiplatelet therapy. On the other hand, one FDA reviewer, Medical\u00a0Team\u00a0Leader Tom Marciniak, raised multiple questions about the validity of the trial and its conclusions because of an alarming amount of early withdrawals and missing data. His view was largely endorsed by several committee members, including Steve Nissen and Sanjay Kaul.<\/p>\n<p>In<a href=\"http:\/\/www.prnewswire.com\/news-releases\/fda-advisory-committee-recommends-against-approval-of-oral-anticoagulant-xarelto-to-reduce-the-risk-of-secondary-cardiovascular-events-in-patients-with-acute-coronary-syndrome-153247295.html\">\u00a0a press release<\/a>, J&amp;J said it &#8220;will ensure the questions raised today are addressed with the FDA.&#8221;<\/p>\n<p><a href=\"http:\/\/cardiobrief.org\/2012\/05\/23\/live-blog-the-fda-advisory-panel-for-rixaroxaban-for-acs\/\">Click here for a detailed account of the panel meeting.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA&#8217;s\u00a0Cardiovascular and Renal Drugs Advisory Committee voted today against adding an indication for acute coronary syndromes (ACS) to the label of the anticoagulant rivaroxaban (Xarelto). The vote was 6 to 4 against approval, with 1 abstention. The advisory panel spent most of the day trying to reconcile diametrically opposed views of the\u00a0pivotal ATLAS ACS [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[495],"tags":[239,1289,366,990],"class_list":["post-29264","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","tag-acs","tag-fda-panel","tag-rivaroxaban","tag-xarelto"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/29264","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=29264"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/29264\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=29264"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=29264"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=29264"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}