The third time wasn’t the charm. The FDA today turned turned down\u00a0\u2014 for the third time\u00a0\u2014 the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto,\u00a0Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke, or death. In addition, the FDA\u00a0\u2014 for the second time\u00a0\u2014 turned down the sNDA for rivaroxaban in the same population for the reduction of stent thrombosis.<\/p>\n
The complete response letters come as little surprise, since\u00a0an FDA advisory panel last month<\/a>\u00a0strongly recommended against approval for the indications. The large amount of missing data from the pivotal ATLAS ACS 2-TIMI 51 trial has been the source of the company’s inability to gain the ACS indications. Although J&J has made considerable efforts to fill in the missing data, the FDA reviewers and panel members did not believe the data were reliable enough to reach firm conclusions about the relative safety and efficacy of rivaroxaban for use in ACS.<\/p>\n \u201cWe remain committed to providing patients who have suffered from acute coronary syndrome with additional protection against stent thrombosis and secondary life-threatening cardiovascular events,\u201d said a J&J executive in a statement. \u201cWe are evaluating the contents of the letters and will determine the appropriate next steps.\u201d<\/p>\n FDA Rescinds Xarelto REMS<\/strong><\/p>\n In a separate development,\u00a0the FDA has rescinded<\/a>\u00a0the Xarelto\u00a0REMS (Risk\u00a0Evalaution and Mitigation Strategy)<\/a>. The company had been required\u00a0to communicate the risks of an increased risk of thrombotic events when the drug was discontinued without an adequate alternative anticoagulant and was of decreased efficacy when not taken with the evening meal.<\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" The third time wasn’t the charm. The FDA today turned turned down\u00a0\u2014 for the third time\u00a0\u2014 the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto,\u00a0Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke, or death. In addition, the FDA\u00a0\u2014 for the second time\u00a0\u2014 turned down the sNDA for rivaroxaban in […]<\/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":[239,492,196,366,253],"class_list":["post-41697","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","category-electrophysiology","category-general","tag-acs","tag-anticoagulation","tag-fda","tag-rivaroxaban","tag-stroke"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/41697","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=41697"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/41697\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=41697"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=41697"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=41697"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}