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MHT's Julie Donnelly: Biotechs lag in social media use
Alkermes Inc. has announced that the U.S. Food and Drug Administration will reconsider its application for a diabetes drug target that was earlier rejected. If approved, it will be the first type 2 diabetes treatment taken once weekly.
The new FDA decision date is October 22, 2010. The drug candidate, called Bydureon, which is co-produced by Cambridge-based Alkermes (Nasdaq: ALKS), San Diego-based Amylin Pharmaceuticals Inc. and Indianapolis-based Eli Lilly and Company is a longer acting form of the already-approved drug, Byetta.
The original application was submitted in May 2009, and the FDA issued a complete response letter in March 2010, requesting additional data before the potential drug could be approved. The companies then completed the request for data last month.
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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