{"id":33898,"date":"2013-01-03T11:52:33","date_gmt":"2013-01-03T16:52:33","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=33898"},"modified":"2013-01-03T11:52:33","modified_gmt":"2013-01-03T16:52:33","slug":"combination-of-ezetimibe-and-atorvastatin-back-on-fda-approval-path","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/01\/03\/combination-of-ezetimibe-and-atorvastatin-back-on-fda-approval-path\/","title":{"rendered":"Combination of Ezetimibe and Atorvastatin Back on FDA Approval Path"},"content":{"rendered":"<p>A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval,\u00a0<a href=\"http:\/\/www.mercknewsroom.com\/press-release\/research-and-development-news\/merck-announces-fda-acknowledgement-resubmission-new-dru\">according to Merck<\/a>, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed &#8220;Son of Vytorin.&#8221; The new drug-application (NDA) submission was<a href=\"http:\/\/cardiobrief.org\/2009\/11\/02\/fda-refuses-to-file-merck-application-for-ezetimibeatorvastatin-combination\/\">\u00a0first rejected by the FDA in 2009<\/a>\u00a0and again\u00a0<a href=\"http:\/\/www.forbes.com\/sites\/matthewherper\/2012\/03\/05\/fda-rejects-son-of-vytorin\/\">last year<\/a>.<\/p>\n<p>Merck said yesterday that the\u00a0FDA had accepted Merck&#8217;s resubmission of its NDA, which included additional data provided by Merck in response to the FDA&#8217;s rejection of the application last year. Merck said it also planned to pursue approval of the drug in other countries.<\/p>\n<p>Despite its potent cholesterol-lowering effects, the clinical benefits of ezetimibe have never been demonstrated, prompting furious debates about the proper role of surrogate endpoints. Last year the FDA rejected\u00a0a new indication\u00a0for Vytorin and \u00a0Zetia (ezetimibe alone) in patients with chronic kidney disease, as the independent effect of ezetimibe had not been assessed in\u00a0<a href=\"http:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(11)60739-3\/fulltext\">SHARP<\/a>, the pivotal study for the indication. Results of the\u00a0<a href=\"http:\/\/clinicaltrials.gov\/show\/NCT00202878\">IMPROVE-IT trial<\/a>, expected this year,\u00a0may finally resolve the question of whether ezetimibe is beneficial.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval,\u00a0according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed &#8220;Son [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[585,210,577,934,1611,576],"class_list":["post-33898","post","type-post","status-publish","format-standard","hentry","category-prevention","tag-atorvastatin","tag-cholesterol","tag-ezetimibe","tag-lipitor","tag-merck","tag-vytorin"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/33898","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=33898"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/33898\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=33898"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=33898"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=33898"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}