Amylin and Alkermes announced that the FDA has approved Bydureon (exenatide extended-release for injectable suspension), a long-acting glucagon-like peptide-1 receptor agonist, for once-weekly treatment of type 2 diabetes.

Bydureon is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings. This approval was based on data from the DURATION clinical trial program in which patients taking once-weekly Bydureon experienced a statistically superior reduction in A1C of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for patients taking Amylin and Lilly‘s Byetta (exenatide injection), a twice-daily form of exenatide, after 24 weeks of treatment. The approval was also based on clinical experience with Byetta.

Bydureon is expected to be available in February 2012.

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