{"id":29882,"date":"2012-06-22T09:53:33","date_gmt":"2012-06-22T13:53:33","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=29882"},"modified":"2012-06-22T09:53:33","modified_gmt":"2012-06-22T13:53:33","slug":"fda-rejects-acs-indication-for-rivaroxaban-xarelto","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/06\/22\/fda-rejects-acs-indication-for-rivaroxaban-xarelto\/","title":{"rendered":"FDA Rejects ACS Indication for Rivaroxaban (Xarelto)"},"content":{"rendered":"<p>The FDA has issued a complete response letter to the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson &amp; Johnson) in patients with acute coronary syndrome (ACS). The action was expected, since last month\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\/\">the\u00a0FDA\u2019s\u00a0Cardiovascular and Renal Drugs Advisory Committee voted against<\/a>\u00a0recommending the new indication, which was based on 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\" target=\"_parent\">pivotal ATLAS ACS 2-TIMI 51 trial<\/a>.<\/p>\n<p>In\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\" target=\"_parent\">a press release<\/a>, a 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. We will continue to work with the FDA to fully address their questions as quickly as possible.\u201d Rivaroxaban is currently approved for the prevention of clots following knee replacement and hip replacement surgery and for the prevention of strokes and blood clots in people with atrial fibrillation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has issued a complete response letter to the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson &amp; Johnson) in patients with acute coronary syndrome (ACS). The action was expected, since last month\u00a0the\u00a0FDA\u2019s\u00a0Cardiovascular and Renal Drugs Advisory Committee voted against\u00a0recommending the new indication, which was based on the\u00a0pivotal ATLAS [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-29882","post","type-post","status-publish","format-standard","hentry"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/29882","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=29882"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/29882\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=29882"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=29882"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=29882"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}