{"id":47872,"date":"2015-04-16T15:13:43","date_gmt":"2015-04-16T19:13:43","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&p=47872"},"modified":"2015-05-15T17:08:32","modified_gmt":"2015-05-15T21:08:32","slug":"cangrelor-finally-gets-nod-from-fda-advisory-panel","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2015\/04\/16\/cangrelor-finally-gets-nod-from-fda-advisory-panel\/","title":{"rendered":"Cangrelor Finally Gets Nod From FDA Advisory Panel"},"content":{"rendered":"

On Wednesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2-1 to recommend\u00a0approval of\u00a0cangrelor during PCI to\u00a0reduce the risk of periprocedural thrombotic events such as MI, stent thrombosis, and ischemia driven revascularization.<\/p>\n

The news follows a decade of efforts to develop the drug\u00a0\u2014 a potent, fast-acting, and reversible \u00a0antiplatelet agent. After the failure of two large clinical trials, the company finally achieved some success with its\u00a0phase 3\u00a0CHAMPION PHOENIX<\/a>\u00a0trial two years ago. But last year the\u00a0FDA raised questions about the trial and withheld approval until the company performed additional analyses.<\/p>\n

The committee spent much of the day trying to determine\u00a0a role for the drug in clinical practice, since it is now intended for use in ad hoc PCI, in which patients undergoing angiography are found to have obstructive coronary artery disease and undergo PCI in the same session. The data suggest that cangrelor may then be beneficial in patients who have not been pretreated with an oral P2Y12 inhibitor. A big\u00a0problem, however, is that there is a very wide degree of variation in the use and acceptance of ad hoc PCI. The committee concluded that in the real world setting the benefits of cangrelor, though modest, outweighed the small increase in the risk of bleeding associated with the drug.<\/p>\n

The FDA is expected to reach a final decision by June 23.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

On Wednesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2-1 to recommend\u00a0approval of\u00a0cangrelor during PCI to\u00a0reduce the risk of periprocedural thrombotic events such as MI, stent thrombosis, and ischemia driven revascularization. The news follows a decade of efforts to develop the drug\u00a0\u2014 a potent, fast-acting, and reversible \u00a0antiplatelet agent. After the failure of […]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[1106,944,2543],"class_list":["post-47872","post","type-post","status-publish","format-standard","hentry","category-interventional-cardiology","tag-cangrelor","tag-fda-advisory-committee","tag-medicines-company"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/47872","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=47872"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/47872\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=47872"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=47872"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=47872"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}