FDA sets new PDUFA action date for exenatide once weekly NDA

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA). The revised action date is the result of the FDA's decision to allow five additional days for its review of pending regulatory applications following the agency's recent five-day weather-related closure.

Exenatide once weekly is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. The NDA for exenatide once weekly was submitted in May 2009 and accepted by the FDA in July 2009.

SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company