Amylin Pharmaceuticals, Inc, Eli Lilly and Company and Alkermes, Inc announced that the US Food and Drug Administration (FDA) has classified the Bydureon (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.
"If approved, Bydureon will be the first once-weekly treatment for type 2 diabetes, and we are committed to making this important therapeutic option available to patients as soon as possible," said Orville G Kolterman, senior vice president of research and development, Amylin Pharmaceuticals. "We will continue to work closely with the agency through this final stage of the review process."
The new drug application (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 (exenatide) injection. The agency issued a complete response letter to the companies in March 2010 and the companies responded to that letter in April 2010.
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, which has been available in the US 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.
Byetta is the first US FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1).