{"id":3312,"date":"2010-09-16T16:40:20","date_gmt":"2010-09-16T20:40:20","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=3312"},"modified":"2011-07-19T17:44:49","modified_gmt":"2011-07-19T21:44:49","slug":"fda-dabigatran-gains-lorcaserin-loses","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/09\/16\/fda-dabigatran-gains-lorcaserin-loses\/","title":{"rendered":"FDA: Dabigatran Gains, Lorcaserin Loses"},"content":{"rendered":"<p>An alternative to warfarin is one step closer to reality. On Thursday, The FDA released <a href=\"http:\/\/www.fda.gov\/AdvisoryCommittees\/Calendar\/ucm224194.htm\">briefing documents<\/a> for next Monday&#8217;s\u00a0meeting of the\u00a0Cardiovascular and Renal Drugs Advisory Committee to discuss the new drug application for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The FDA reviewers agreed that dabigatran was at least as safe and effective as warfarin in the RE-LY trial. Cardiologists on the panel include the acting chair, A. Michael Lincoff, along with Steve Nissen, Sanjay Kaul, and Darren McGuire.<\/p>\n<p>Also on Thursday, the FDA&#8217;s\u00a0Endocrinologic and Metabolic Drugs Advisory Committee recommended against approval of the diet drug lorcaserin (Lorqess, Arena). The vote was 9-5. Panel members felt the drug&#8217;s slim margin of efficacy in producing weight loss did not outweigh safety concerns that might arise in the real world.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>An alternative to warfarin is one step closer to reality. On Thursday, The FDA released briefing documents for next Monday&#8217;s\u00a0meeting of the\u00a0Cardiovascular and Renal Drugs Advisory Committee to discuss the new drug application for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The FDA reviewers agreed that dabigatran was at [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[339,196,408,342],"class_list":["post-3312","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-dabigatran","tag-fda","tag-lorcaserin","tag-spaf"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/3312","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=3312"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/3312\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=3312"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=3312"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=3312"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}