New FDA roadblock delays Novo's blockbuster contender degludec

Novo Nordisk's ambitious plan to tackle Sanofi's Lantus franchise for diabetes with its late-stage insulin degludec ran into another regulatory roadblock today. The FDA has decided to schedule an advisory panel review for the long-acting insulin on November 8, past the current PDUFA date.

The FDA had already delayed its review of degludec by three months to allow for "further data clarification and analyses." Now analysts say that Novo ($NVO), which believes degludec can rival Lantus, a drug that generates up to $5 billion a year, will have to wait until early 2013 before it can learn whether it has a green light to start marketing the drug.

"It is hard to say what kind of a delay we are talking about," a Novo spokesperson told Reuters. "There are examples of when the FDA has made decisions just five or six weeks after advisory committee meetings have been held, and sometimes it takes months."

A few weeks ago at the big ADA confab, Novo Nordisk touted degludec's superior performance to Lantus in reducing instances of night-time hypoglycemia, when blood sugar levels plunge. Novo says that in a head-to-head study--an increasingly popular strategy for late-stage drugs designed to go after a big competitor--its experimental degludec reduced nocturnal hypoglycemia 36% compared with Lantus.

Sanofi ($SNY) in turn blasted back that Novo's study design had skewed the data, giving degludec an unfair advantage. Novo officials indignantly rejected the accusation.

- get the press release
- here's the Reuters story