Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Eli Lilly, Amylin Pharmaceuticals and Alkermes have received marketing authorization approval to BYDUREON (exenatide 2 mg powder and solvent for prolonged release suspension for injection) from the European Commission.
Subscribe to our email newsletter
The EU marketing authorization of BYDUREON is based on review of the submission package, including 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 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.
The BYDUREON submission builds upon six years of market experience with BYETTA (exenatide) injection, the twice-daily form of exenatide that is available in more than 70 countries worldwide.
BYDUREON is delivered using a biodegradable microsphere technology developed by Alkermes.
Amylin and Lilly partnered to develop BYDUREON, which is based on proprietary technology for long-acting medications developed by Alkermes.