Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Apr 23 2010

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today 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.

“We are committed to making BYDUREON available to patients as soon as possible and will continue to work closely with the agency toward our goal.”

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," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "We are committed to making BYDUREON available to patients as soon as possible and will continue to work closely with the agency toward our goal."

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^® (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.

The NDA for BYDUREON was submitted in May 2009 and was based on data from the DURATION clinical trial program, as well as more than seven years of clinical experience with BYETTA. The NDA was accepted by the FDA in July 2009. The agency issued a complete response letter to the companies in March 2010.