Amylin, Alkermes Get New FDA Date

5/6/10

San Diego-based Amylin Pharmaceuticals (NASDAQ: AMLN) and its partners, Indianapolis-based Eli Lilly and Waltham, MA-based Alkermes (NASDAQ: ALKS), said today the FDA has set a deadline of Oct. 22 to finish reviewing the application to start selling exenatide once-weekly (Bydureon) for diabetes. The first application was filed in May 2009, and the FDA said in March that it wasn’t ready to be approved yet. Regulators aren’t requiring new clinical trials, although the companies said in March that issues remained around finalizing the prescribing information that guides physicians, along with a Risk Evaluation and Mitigation Strategy (REMS) program, and “clarification of existing manufacturing processes.”

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