EC approves Bydureon

The European Commission approved an MAA from Eli Lilly and Co. (NYSE:LLY) for Bydureon exenatide once weekly to treat Type II diabetes in adults. The long-acting release (LAR) formulation of synthetic exendin-4 is indicated for use in combination with metformin, a sulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a thiazolidinedione. Lilly plans to begin launching the product in 3Q11, according to partner Amylin Pharmaceuticals Inc. (NASDAQ:AMLN). The companies co-developed Bydureon, which uses drug delivery technology from Alkermes Inc. (NASDAQ:ALKS).

Last October, FDA issued a second complete response letter for Bydureon requesting a thorough QT study, as well as data from the Phase III DURATION-5 trial. Amylin said the MAA submission included data from DURATION-5, but not from the tQT study, which is ongoing (see BioCentury, Oct. 25, 2010). ...