Diabetes Treatment Bydureon Approved in Europe

The EU approval for Bydureon was based on a submission package that included data from studies in the DURATION clinical program.

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.

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.

A glucagon-like peptide