Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON(TM)

Apr 22, 2010 - Classification of Submission and New PDUFA Action Date Expected Within 14 Days, per FDA Guidelines -Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension). In accordance with its guidelines, the FDA is expected to classify the complete response as a Class 1 or Class 2 resubmission, and also provide the companies with an updated Prescription Drug User Fee Act (PDUFA) target action date within the next two weeks.

The companies' reply addresses requests from the FDA primarily related to finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.

The FDA's complete response letter did not request new pre-clinical or clinical trials, nor did it contain requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility. All of these observations have been addressed.

"The companies have worked diligently and quickly over the last few weeks to submit a complete response and are confident we addressed the requests that were outlined by the FDA,"...

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...BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA(R) (exenatide) injection, which has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes. BYDUREON and BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications... Alkermes' Press Release - Eli Lilly's Press Release - Amylin's Press Release -