Amylin Pharmaceuticals, Eli Lilly and Company, and Alkermes, Inc. announced that a New Drug Application (NDA) for exenatide once weekly has been submitted to the FDA as a subcutaneous injectable treatment of type 2 diabetes. The NDA submission includes data from the DURATION-1 study and the meta-analysis of primary cardiovascular events across the Byetta (exenatide, from Amylin and Lilly) clinical database. DURATION-1 was designed to test the superiority of exenatide once weekly, as compared to Byetta, which is administered twice daily. In this study, exenatide once weekly treatment resulted in statistically significant reductions in A1C of 1.9 percentage points from baseline, compared to a reduction of 1.5 percentage points for Byetta. Seventy-seven percent of patients treated with exenatide once weekly achieved an A1C of 7 percent or less compared to 61 percent of patients treated with Byetta.
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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