Alkermes diabetes drug gets second chance

Alkermes Inc. said the U.S. Food and Drug Administration will reconsider its application for a diabetes drug target whose previous submission for regulatory approval was rejected earlier this year.

The FDA’s new decision date is Oct. 22. The drug candidate, Bydureon, which is co-produced by Cambridge, Mass.-based Alkermes, San Diego-based Amylin Pharmaceuticals and Indianapolis-based Eli Lilly and Co., is a longer-acting form of the already-approved drug Byetta.

The original application was submitted in May 2009, and the FDA issued a so-called complete response letter in March. That letter requested additional data before the potential drug could be approved.

Byetta has been associated with acute pancreatitis, which can be fatal. It should not be used by people who have severe kidney problems, according to the drug’s label.

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Boston Business Journal - by Julie M. Donnelly