{"id":16206,"date":"2012-02-23T09:53:41","date_gmt":"2012-02-23T14:53:41","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=16206"},"modified":"2012-02-23T10:52:38","modified_gmt":"2012-02-23T15:52:38","slug":"fda-advisory-panel-gives-green-light-to-qnexa-diet-pill","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/02\/23\/fda-advisory-panel-gives-green-light-to-qnexa-diet-pill\/","title":{"rendered":"FDA Advisory Panel Gives Green Light to Qnexa Diet Pill"},"content":{"rendered":"<p>Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of \u00a0phentermine and topiramate\u00a0under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this would have to be completed prior to approval.<\/p>\n<p>Birth defects associated with Qnexa were another source of concern. The panel expressed strong support for a risk evaluation and mitigation strategy (REMS) to accompany any approval. But the panel ultimately was impressed by data showing a 10% weight loss at 2 years for people taking the drug.<\/p>\n<p>Of all the obesity drugs, this one &#8220;has the highest efficacy in terms of weight loss,&#8221; panel member Sanjay Kaul told\u00a0<a href=\"http:\/\/www.bloomberg.com\/news\/2012-02-22\/vivus-weight-loss-pill-qnexa-wins-backing-of-fda-advisory-panel.html\">Bloomberg News<\/a>. &#8220;That shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,\u201d\u00a0.<\/p>\n<p>Kaul told CardioExchange that the 20-2 vote appears more enthusiastic than the actual sentiment of the panel. Panel members remain concerned about the uncertainty regarding cardiovascular risk, including the possible adverse effects on blood pressure and heart rate. Kaul said the panel was impressed by the company\u2019s proposed REMS, but there is little evidence demonstrating that even a strong REMS can significantly reduce adverse outcomes like birth defects.<\/p>\n<p>Two other diet drugs, Contrave, the combination of\u00a0naltrexone and bupropion, from Orexigen, and\u00a0locaserin, from Arena, have been struggling to gain FDA approval in recent years. No new diet drug has been approved for marketing in the U.S. since 1999.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of \u00a0phentermine and topiramate\u00a0under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[985,944,1151],"class_list":["post-16206","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-diet-drugs","tag-fda-advisory-committee","tag-qnexa"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/16206","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=16206"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/16206\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=16206"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=16206"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=16206"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}