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FDA approves Amylin and Alkermes Bydureon

By Lianne Dane

Created 01/27/2012 - 15:24

 The FDA on Friday approved Amylin and Alkermes’ Bydureon (extended-release exenatide) for adults with type 2 diabetes. The approval, which comes on the third attempt, makes Bydureon the only once-weekly diabetes therapy available in the US market.

 As a condition of approval, Amylin must conduct a post-approval clinical trial to determine whether the treatment increases cardiovascular risks.

 Bydureon was approved in Europe last June. In November, Amylin and Eli Lilly terminated an existing diabetes drug collaboration, resulting in the rights to Byetta and Bydureon being transferred to Amylin.