Novo Nordisk: Approval of New Diabetes Drug Is Further Postponed

Novo Nordisk (NVO), a company that has a vested interest in the diabetes market, is out with a new report pegging the cost of treating the disease at nearly a quarter-trillion dollars.

According to the "National Changing Diabetes Program" which is sponsored by NVO, the "widely accepted" figure has been $174 billion. But Novo commissioned The Lewin Group, a pharma consulting group, to broaden things out for what it's calling "The National Diabetes Economic Barometer." And all in, the study says a more accurate number for U.S. diabetes care and lost productivity in 2007 is $217.5 billion.

The report factors in an estimated additional $18 billion spent on treating more than six million Americans who don't know they have diabetes, $25 billion to take care of 57 million people with what's known as pre-diabetes, and $623 million on 180,000 pregnant women who got gestational diabetes.

Novo Nordisk has filed for Food and Drug Administration approval of a new type of once-a-day injectable diabetes drug. It's expected to get reviewed by an advisory committee next March. That's an outside panel of experts that recommends to the agency whether it should approve a drug. The FDA usually, but not always, follows the advice of such committees. Word is if it's approved, NVO would call the drug "Victoza" for commercial purposes.

Is it too close to "victory" as in winning the battle against diabetes? I'm almost certain that if that's the brand name Novo wants, the FDA will scrutinize it. For now it's known by the mouthful liraglutide (lur-rag-loo-tide). If the drug comes to market it would compete against the twice-a-day injectable Byetta from Amylin Pharmaceuticals (AMLN) and the Januvia pill from Merck (MRK). Amylin and its partners Eli Lilly (LLY) and Alkermes (ALKS) are also hoping to one-up NVO with a once-a-week version of Byetta, but the fate and timeline of that product is uncertain.

Some public health experts and advocates argue that new drugs aren't the solution to the fast-growing diabetes epidemic. They believe we need to move "upstream" with better education, eating and exercise habits and earlier diagnosis. Easier said than done.

Update: Novo Nordisk just issued this press release that the FDA advisory committee meeting on liraglutide has been postponed from March 2nd to April 2nd or 3rd. So, that means the potential FDA approval of the drug likely gets pushed into next year even further.