Ryzodeg insulin degludec/insulin aspart regulatory update

FDA is concerned about the cardiovascular safety of 2 Novo Nordisk insulin products under review for Type I and II diabetes, according to a document made public ahead of the Nov. 8 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to discuss NDAs for the products. The document - a conflict-of-interest waiver for a physician participating in the meeting - stated that "meta-analyses of several clinical trials suggest an excess risk for cardiovascular events" with Tresiba insulin Degludec and Ryzodeg insulin Degludec/insulin aspart over comparators. Briefing documents are usually released to the public 2 business days before an FDA meeting. The meeting will occur after the products' Oct. 29 PDUFA date, but Novo has said it could not speculate on when a decision would be made until after the meeting. ...