{"id":35063,"date":"2013-03-05T15:01:41","date_gmt":"2013-03-05T20:01:41","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=35063"},"modified":"2013-03-05T15:01:41","modified_gmt":"2013-03-05T20:01:41","slug":"fda-again-rejects-acs-indication-for-rivaroxaban","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/03\/05\/fda-again-rejects-acs-indication-for-rivaroxaban\/","title":{"rendered":"FDA Again Rejects ACS Indication for Rivaroxaban"},"content":{"rendered":"<p>For the second time the FDA has turned down the supplemental new drug application (sNDA) for the proposed indication of rivaroxaban (Xarelto,\u00a0Johnson &amp; Johnson) to treat patients with acute coronary syndrome (ACS).<\/p>\n<p>Despite early hopes, the ACS indication has proved tantalizingly elusive for the drug. \u00a0When 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>\u00a0was unveiled in 2011 it was widely praised. Great expectations were enhanced when the FDA granted priority review for the ACS indication in February 2012. But a few months later the momentum ground to a halt when\u00a0<a title=\"Rivaroxaban for ACS Gets Positive FDA Review, but Questions About ATLAS Trial Conduct Persist\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/rivaroxaban-for-acs-gets-positive-fda-review-but-questions-about-atlas-trial-conduct-persist\/\">FDA reviewers raised questions about the ATLAS trial<\/a>. Shortly afterwards, the FDA&#8217;s\u00a0Cardiovascular and Renal Drugs Advisory Committee\u00a0<a title=\"FDA Advisory Committee Recommends Against ACS Indication for Rivaroxaban\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/fda-advisory-committee-recommends-against-acs-indication-for-rivaroxaban\/\">voted<\/a>\u00a0against the ACS indication.<\/p>\n<p>The FDA issued\u00a0<a title=\"FDA Rejects ACS Indication for Rivaroxaban (Xarelto)\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/fda-rejects-acs-indication-for-rivaroxaban-xarelto\/\">the first complete response letter<\/a>\u00a0rejecting the sNDA last June.\u00a0In\u00a0<a href=\"http:\/\/www.prnewswire.com\/news-releases\/fda-issues-complete-response-letter-for-xarelto-rivaroxaban-for-the-reduction-of-secondary-cardiovascular-events-in-patients-with-acute-coronary-syndrome-159935025.html\">a press release<\/a>\u00a0issued at the time,\u00a0a J&amp;J company official said the company remains \u201cconfident in the robust results of the ATLAS ACS 2 TIMI 51 trial and the positive benefit-risk profile of rivaroxaban in patients with ACS.\u201d<\/p>\n<p>In\u00a0<a href=\"http:\/\/www.marketwatch.com\/story\/fda-issues-complete-response-letter-for-xarelto-rivaroxaban-for-the-reduction-of-cardiovascular-events-in-patients-with-acute-coronary-syndrome-2013-03-04\">a new press release<\/a>\u00a0issued on Monday afternoon the company restated its confidence &#8220;in the robustness and results&#8221; of the ATLAS \u00a0trial. Criticism of ATLAS from the FDA and the advisory panel members had focused on missing data from the ATLAS trial. In today&#8217;s press release J&amp;J provided more information about its efforts to address this question:<\/p>\n<blockquote><p>On September 6, 2012, Janssen submitted to the FDA important data related to patients who had withdrawn from the ATLAS ACS 2 TIMI 51 trial&#8230; as part of its complete response.<\/p>\n<p>To compile these data, the company undertook a global effort and was able to confirm the vital status information for 843, or 63%, of the 1,338 trial participants who previously had unknown vital status. The mortality benefit observed during the treatment phase of the study was maintained. These new events were distributed equally between the three treatment groups (2.5 mg, 5 mg and placebo) of patients who were alive (806) and those who had died (37). After these efforts, follow up data was not available on only 2.4% of patients.<\/p><\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>For the second time the FDA has turned down the supplemental new drug application (sNDA) for the proposed indication of rivaroxaban (Xarelto,\u00a0Johnson &amp; Johnson) to treat patients with acute coronary syndrome (ACS). Despite early hopes, the ACS indication has proved tantalizingly elusive for the drug. \u00a0When the\u00a0pivotal ATLAS ACS 2-TIMI 51 trial\u00a0was unveiled in 2011 [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[495,1],"tags":[],"class_list":["post-35063","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","category-general"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/35063","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=35063"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/35063\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=35063"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=35063"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=35063"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}