Diabetes drug gets FDA nod, but who'll sell it?

These days, diabetes is where it's at. There's so much activity in the diabetes business, it's tough to keep track. Eli Lilly and Amylin-- have they submitted their app for once-weekly Byetta? What's up with that AstraZeneca/Bristol-Myers Squibb treatment Onglyza? And what about Victoza (liraglutide)? (The answers are Yes, Still awaiting FDA approval, and On the way to Euro-OK but waiting on FDA, respectively.)

Beating all those to market, however, is Cycloset, a VeroScience drug that got FDA approval yesterday. Curiouser and curiouser, the drug is a tweaked version, not of another diabetes remedy, but of a Parkinson's disease drug. It works on the brain to control blood sugar, increasing the activity of the neurotransmitter dopamine, so it's unlike any other diabetes drug on the market, the company says.

It's the also first drug approved under new FDA guidelines that require studies showing diabetes meds don't increase cardiovascular risks. And it's a once-daily pill. "For patients newly diagnosed with Type 2 diabetes or those who cannot adequately control their blood sugar with currently available medications, Cycloset provides a completely new approach to treating diabetes," Dr. J. Michael Gaziano, principal investigator, said in a statement.

Sounds good, eh? If VeroScience were all ready to launch Cycloset, sure. But it's not. The drugmaker is looking for a distributor. So that gives Lilly, Amylin, AstraZeneca, et al, time to dicker with regulators over their products.

- read the VeroScience release
- see the story in the Orange County Register

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