Sponsored Links

UPDATE 1-U.S. FDA sets review for Amylin diabetes drug

Wed Aug 10, 2011 4:40pm EDT

* FDA review deadline is January 28, 2012

* Bydureon application resubmitted in July

LOS ANGELES Aug 10 (Reuters) - The U.S. Food and Drug Administration has set a Jan. 28, 2012 deadline for its review of a diabetes drug being developed by Amylin Pharmaceuticals Inc AMLN.O, Eli Lilly and Co (LLY.N) and Alkermes Inc (ALKS.O).

The companies submitted an application for the drug, Bydureon, last month after the regulatory agency declined on two separate occasions to approve it.

The FDA asked last year for more data on Bydureon's impact on the heart before deciding whether to clear it as a treatment for Type 2 diabetes.

Amylin said in early July that a trial of exenatide, the active ingredient in Bydureon, found no link between the drug and changes in heart rhythms. (Reporting by Deena Beasley. Editing by Robert MacMillan)

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.