Amylin, partners respond to FDA's Bydureon request

Fri, 04/23/2010 - 3:17am
The Associated Press

Amylin Pharmaceuticals Inc. and its partners say they have responded to a Food and Drug Administration request for more information on the potential diabetes drug Bydureon.

The companies, which include Eli Lilly & Co. and Alkermes Inc., said Thursday the FDA could take two weeks to set a new target date for a regulatory decision.

In March, the FDA requested more information on manufacturing and a risk mitigation plan for the drug.

Bydureon, or exenatide, is a once-weekly version of the injectable treatment Byetta, which is currently taken twice daily. It is part of the broader GLP-1 class of drugs, which work by increasing the body's insulin production.

The FDA approved Novo Nordisk's once-daily GLP-1 drug Victoza in January. That drug had been under review for two years as safety concerns slowed down the regulatory process. The FDA approved it with a warning over the risk of thyroid cancer.

Shares of Amylin, based in San Diego, closed at $20.54 Thursday, while shares of Eli Lilly, based in Indianapolis, closed at $35.38. Shares of Alkermes, based in Waltham, Mass., closed at $13.40.


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