FDA further delays Novo Nordisk's ultra long-acting insulin products Tresiba and Ryzodeg

Denmark’s Novo Nordisk (NOV: N), the world’s largest insulin maker, says that the US Food and Drug Administration has told the company that an FDA Advisory Committee meeting is tentatively scheduled to be held on November 8, 2012 to discuss the New Drug Applications for the ultra-long-acting insulin Tresiba (insulin degludec) and insulin combination analogue Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes.

This further delay is a clear disappointment for Novo Nordisk, the world’s largest insulin maker, which has touted the products as having blockbuster potential, ie, annual sales of over $1 billion, and set to compete with Sanofi’s Lantus (insulin glargine), which holds some 80% of the global market for long-acting insulins and sales of around $5 billion last year. The company’s shares, which have risen 34% so far this year, dipped 1% to 884 Danish kroner on the news.

FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing NDAs. According to the FDA Amendment Act of 2007 (FDAAA), the FDA should refer new drugs to an advisory committee meeting, or alternatively justify why an advisory committee meeting was not requested.