{"id":32030,"date":"2012-09-27T17:27:15","date_gmt":"2012-09-27T21:27:15","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=32030"},"modified":"2012-09-27T17:27:15","modified_gmt":"2012-09-27T21:27:15","slug":"fda-sets-new-decision-date-for-eliquis-apixaban","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/09\/27\/fda-sets-new-decision-date-for-eliquis-apixaban\/","title":{"rendered":"FDA Sets New Decision Date for Eliquis (Apixaban)"},"content":{"rendered":"<p>The FDA \u00a0will decide the fate of\u00a0apixaban (Eliquis) by March 17, 2013. The new\u00a0Prescription Drug User Fee Act (PDUFA) goal date was announced yesterday by the drug&#8217;s manufacturers, Pfizer and Bristol-Myers Squibb.<\/p>\n<p>The new drug application (NDA) for apixaban for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was\u00a0<a title=\"ARISTOTLE Finds the Golden Mean of Anticoagulation\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/aristotle-finds-the-golden-mean-of-anticoagulation-2\/\">highly praised<\/a>\u00a0when it was first published, the FDA first\u00a0<a title=\"Decision on Apixaban (Eliquis) Pushed Back By 3 Months\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/decision-on-apixaban-eliquis-pushed-back-by-3-months\/\">extended its review by 3 months<\/a>\u00a0and then\u00a0<a title=\"FDA Once Again Delays Approval of Apixaban (Eliquis)\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/fda-once-again-delays-approval-of-apixaban-eliquis\/\">issued a complete response letter (CRL)<\/a>\u00a0on June 25 requesting &#8220;additional information on data management and verification from the ARISTOTLE trial.&#8221; According to Pfizer and Bristol-Myers Squibb, the FDA has now accepted for evaluation their response to the CRL.<\/p>\n<p>In Europe last week, the Committee for Medicinal Products for Human Use (CHMP)\u00a0<a title=\"Apixaban (Eliquis) For Atrial Fibrillation Gets Positive European Recommendation\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/apixaban-eliquis-for-atrial-fibrillation-gets-positive-european-recommendation\/\">recommended approval for apixaban<\/a>\u00a0for the same indication.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA \u00a0will decide the fate of\u00a0apixaban (Eliquis) by March 17, 2013. The new\u00a0Prescription Drug User Fee Act (PDUFA) goal date was announced yesterday by the drug&#8217;s manufacturers, Pfizer and Bristol-Myers Squibb. The new drug application (NDA) for apixaban for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was\u00a0highly [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[495,13],"tags":[363,1156,1154,342,1032],"class_list":["post-32030","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","category-electrophysiology","tag-apixaban","tag-eliquis","tag-oral-anticoagulants","tag-spaf","tag-stroke-prevention-in-af"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/32030","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=32030"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/32030\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=32030"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=32030"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=32030"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}