The European Commission has granted marketing authorization to Eli Lilly, Amylin Pharmaceuticals and Alkermes’ type 2 diabetes drug Bydureon (exenatide extended-release for injectable suspension). Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist, and is the first once-weekly treatment for type 2 diabetes. It delivers glycemic control in a single weekly dose and is indicated for the treatment of type 2 diabetes in adult patients in combination with metformin, a sulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a thiazolidinedione.
The EU Marketing Authorization of Bydureon is based on review of the submission package, including data from studies in the Bydureon clinical program in which exenatide resulted in improvements in glycemic control with just one dose per week. In the data submitted, Bydureon showed statistically significant improvements in glycemic control based on reduction of A1c between 1.5 and 1.9 percent after six months.
In the U.S., the New Drug Application for Bydureon was submitted to the U.S. Food and Drug Administration (FDA) in 2009. The FDA issued a complete response letter and requested further data in late 2010. The companies plan to submit a response in the second half of 2011.