{"id":31960,"date":"2012-09-21T11:35:55","date_gmt":"2012-09-21T15:35:55","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=31960"},"modified":"2012-09-21T11:35:55","modified_gmt":"2012-09-21T15:35:55","slug":"apixaban-eliquis-for-atrial-fibrillation-gets-positive-european-recommendation","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/09\/21\/apixaban-eliquis-for-atrial-fibrillation-gets-positive-european-recommendation\/","title":{"rendered":"Apixaban (Eliquis) For Atrial Fibrillation Gets Positive European Recommendation"},"content":{"rendered":"<p><a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Summary_of_opinion\/human\/002148\/WC500132869.pdf\">The European\u00a0Committee for Medicinal Products for Human Use (CHMP) has recommended approval for apixaban (Eliquis, Pfizer and BristolMyers Squibb) for atrial fibrillation.<\/a> The drug is already approved in Europe\u00a0for the prevention of venous thromboembolic events following hip or knee replacement surgery. The drug has\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\/\">not yet been approved<\/a>\u00a0in the United States.<\/p>\n<p>Here is the CHMP-proposed indication for\u00a0the existing 2.5 mg dose and a new 5 mg dose:<\/p>\n<blockquote><p>\u201cPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age \u2265 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class \u2265 II).\u201d<\/p><\/blockquote>\n<p>The CHMP proposed that apixaban should be contraindicated in patients at high risk for major bleeding and in patients receiving other anticoagulants.<\/p>\n<p>The CHMP decision was based\u00a0on data from the\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\/\">ARISTOTLE<\/a>\u00a0and\u00a0<a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1007432\">AVERROES<\/a>\u00a0pivotal clinical trials.<\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"http:\/\/cardiobrief.files.wordpress.com\/2012\/09\/eliquis-chmpt-pdf-20sept2012.pdf\"><br \/>\n<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The European\u00a0Committee for Medicinal Products for Human Use (CHMP) has recommended approval for apixaban (Eliquis, Pfizer and BristolMyers Squibb) for atrial fibrillation. The drug is already approved in Europe\u00a0for the prevention of venous thromboembolic events following hip or knee replacement surgery. The drug has\u00a0not yet been approved\u00a0in the United States. Here is the CHMP-proposed indication [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[495,13,1],"tags":[363,341,1156,1154,342],"class_list":["post-31960","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","category-electrophysiology","category-general","tag-apixaban","tag-atrial-fibrillation","tag-eliquis","tag-oral-anticoagulants","tag-spaf"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31960","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=31960"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31960\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=31960"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=31960"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=31960"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}