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. BYETTA has been available in the U.S. since June 2005 and is used in more than 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 is based on data that include the DURATION-1 head-to-head clinical study, safety data from DURATION-2 and more than seven years of clinical experience with BYETTA. The agency issued a complete response letter to the companies in March 2010 and in May 2010 classified the companies' first complete response as a Class 2 resubmission with a PDUFA action date of October 22, 2010.

SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; Alkermes, Inc.