Amylin Pharmaceuticals, Inc, Eli Lilly and Company and Alkermes, Inc confirmed that the US 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 US 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 US FDA in July 2009.
Amylin, Lilly and Alkermes are working together to develop exenatide once weekly, a subcutaneous injection of exenatide for the treatment of type-2 diabetes based on Alkermes' proprietary Medisorb technology for long-acting medications.