Bydureon, the once-weekly diabetes treatment developed by Lilly, Amylin and Alkermes, has received marketing authorization in Europe. The marketing submission was built upon six years of market experience with Bydureon's precursor, Byetta injection, the twice-daily form of exenatide that was developed by Lilly and Amylin. Bydureon is delivered using a biodegradable microsphere technology developed by Alkermes.
A glucagon-like peptide-1 (GLP-1) receptor agonist, Bydureon 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 approval was based on a submission package that included data from studies in the DURATION 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 (a measure of average blood sugar over three months) between 1.5% and 1.9% after six months.
According to an Amylin statement, although Bydureon was not studied as a weight-loss product, most patients taking it lost weight. 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 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.