Bydureon Approved for Once-Weekly Treatment of Type 2 Diabetes
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.
For more information, call (877) 700-7365 or visit www.bydureon.com.