Amylin Pharmaceuticals, Eli Lilly and Company, and Alkermes, Inc. announced that the FDA has accepted for review the New Drug Application (NDA) submitted for once-weekly exenatide as a subcutaneous injectable treatment of type 2 diabetes. The NDA is based on results from the DURATION-1 study and the meta-analysis of primary cardiovascular events across the Byetta clinical database. Exenatide is the active ingredient in Byetta (exenatide, from Amylin and Lilly). DURATION-1 was designed to test the superiority of exenatide once-weekly, as compared to Byetta, which is administered twice daily
Presently, Byetta is approved as an adjunct to metformin, a sulfonylurea, a thiazolidinedione, or in combination with metformin and a sulfonylurea or metformin and a thiazolidinedione in patients with type 2 diabetes without adequate glycemic control.
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