FDA discloses concerns on Novo insulins
FDA is concerned about the cardiovascular safety of two Novo Nordisk A/S (CSE:NVO; NYSE:NVO) 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 news sent shares of Novo Nordisk sliding in New York, with the stock off $9.68 to $157.74 on Thursday. The slide translates into a $5.3 billion loss in market cap for a closing valuation of $86.6 billion.
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 two 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. ...