Eli Lilly, along with Amylin Pharmaceuticals and Alkermes, has announced that the European Commission has granted marketing authorization to Bydureon (exenatide 2 mg powder and solvent for prolonged release suspension for injection).
Bydureon, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a once-weekly treatment for type 2 diabetes that delivers glycemic control 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 DURATION trial 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, according to the companies. The most common side effect with Bydureon in clinical trials was mild-to-moderate nausea, which affected approximately 20 percent of patients and decreased over time in most patients. Other common side effects were vomiting, diarrhea and constipation.
In the U.S., the new drug application for Bydureon (exenatide extended-release for injectable suspension) was submitted to the FDA in 2009. The agency 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. Bydureon is the proposed U.S. trade name.
Bydureon is delivered using a biodegradable microsphere technology developed by Alkermes. The medicine offers a continuous release of exenatide with just one weekly dose.