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UPDATE: FDA Approves BYDUREON, for Type 2 Diabetes


Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved BYDUREON™ (exenatide extended-release for injectable suspension) – the first once-weekly treatment for type 2 diabetes. BYDUREON is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings. BYDUREON will be available in pharmacies nationwide in February.

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"With BYDUREON, U.S. physicians and patients can now choose a therapy that offers continuous blood sugar control in just one dose per week," said John Buse, M.D., Ph.D., professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control."

The approval of BYDUREON (pronounced by-DUR-ee-on) was based on safety and efficacy data from the DURATION clinical trial program, in which treatment with BYDUREON resulted in improvements in glycemic control with just one dose per week. The approval was also based on clinical experience with BYETTA® (exenatide) injection, a twice-daily form of exenatide that has been available in the U.S. since June 2005 and is used in nearly 80 countries worldwide. BYDUREON uses Alkermes' proprietary technology for long-acting medications to provide a controlled release of exenatide.

Posted-In: News FDA


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