The world’s largest insulin producer, Novo Nordisk (NYSE:NVO), announced a major setback this morning in development of its latest diabetes product Degludec. The FDA decided to seek advice from an outside panel of experts and has delayed degludec’s review process at least until November. The announcement comes after an earlier delay in June, when the FDA moved review into late October. NVO has touted the new long-lasting basal insulin as a major challenger to Sanofi’s (NYSE:SNY) Lantus, and believes it may be the next diabetes blockbuster. Lantus had sales over $5B last year, capturing roughly 80% of the market.
The delay will likely push launch of the treatment into 2013, although Novo Nordisk says the FDA has made no mention of an official approval date. Investors are disappointed with the news as many have been holding out since June’s original review date. Shares of Novo Nordisk are down slightly this morning. Notwithstanding, estimates should remain in-line with earlier expectations.