{"id":34653,"date":"2013-02-11T14:49:43","date_gmt":"2013-02-11T19:49:43","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&p=34653"},"modified":"2013-02-11T14:49:43","modified_gmt":"2013-02-11T19:49:43","slug":"fda-wants-cardiovascular-safety-data-before-approving-insulin-degludec","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/02\/11\/fda-wants-cardiovascular-safety-data-before-approving-insulin-degludec\/","title":{"rendered":"FDA Wants Cardiovascular Safety Data Before Approving Insulin Degludec"},"content":{"rendered":"

The FDA informed\u00a0Novo Nordisk\u00a0on Friday that it would not approve the company’s highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But the committee also unanimously recommended that the company be required to perform a cardiovascular outcomes trial.<\/p>\n

In a Complete Response Letter, the FDA told\u00a0Novo Nordisk\u00a0that it will require “additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed.” In\u00a0a press release,<\/a> Novo Nordisk\u00a0said it did not expect it would be able to supply the requested data this year. Sanford Bernstein analyst Timothy\u00a0Anderson\u00a0speculated that the earliest possible date for approval is now 2015.\u00a0Anderson\u00a0also noted that the delay for insulin degludec would help to bolster\u00a0Sanofi’s insulin glargine (Lantus) franchise.<\/p>\n

Novo Nordisk\u00a0CEO, Lars Rebien S\u00f8rensen, said: \u201cWe are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

The FDA informed\u00a0Novo Nordisk\u00a0on Friday that it would not approve the company’s highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But the committee […]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[200,196,1270,1673],"class_list":["post-34653","post","type-post","status-publish","format-standard","hentry","category-general","tag-diabetes","tag-fda","tag-insulin","tag-insulin-degludec"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/34653","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=34653"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/34653\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=34653"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=34653"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=34653"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}