Amylin Pharmaceuticals, Eli Lilly, and Alkermes have reported that the FDA has acknowledged the companies’ BYDUREON (exenatide extended-release for injectable suspension) resubmission. The FDA has categorized it as a class II resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012. BYDUREON is an investigational medication for type 2 diabetes.
“If approved, we believe BYDUREON will be an important new option for type 2 diabetes patients, as the first once-weekly treatment available in the U.S.,” said Christian Weyer, M.D., senior vice president, research and development, Amylin Pharmaceuticals.
BYDUREON is 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 more than 70 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 New Drug Application for BYDUREON was submitted in May 2009. It is based on safety and efficacy data from the DURATION clinical trial program and the BYETTA NDA, as well as post-marketing experience with BYETTA. The FDA issued complete response letters to the companies in March 2010 and October 2010.
BYDUREON received marketing authorization in the European Union in June 2011. It is available in the UK and will soon launch in other major European countries.