The FDA has approved Bydureon Pen (exenatide extended-release for injectable suspension; Bristol-Myers Squibb and AstraZeneca) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Bydureon Pen is the first once-weekly treatment for adults with type 2 diabetes.

Bydureon Pen is a prefilled, single-use pen injector where patients no longer need to transfer the medicine between a vial and syringe during the self-injection process.  Exenatide is delivered via microsphere technology requiring no titration. The Pen formulation contains the same 2mg dose as the original Bydureon single-dose tray.

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The approval was based on a 24-week, randomized, open-label trial, where once-weekly Bydureon showed an HbA1c reduction of 1.6 percentage points vs. 0.9 percentage points for twice-daily Byetta (exenatide; Bristol-Myers Squibb and AstraZeneca) injection at 24 weeks (baseline HbA1c 8.5% and 8.4%, respectively).

Bydureon Pen will be available later this year. Bydureon single-dose tray will continue to remain commercially available.

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