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FDA Approves BYDUREON™ - The First and Only Once-Weekly Treatment for Type 2 Diabetes

Glycosmedia, 2012

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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.
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.
BYDUREON uses Alkermes ' proprietary technology for long-acting medications to provide a controlled release of exenatide.
"As the first and only once-weekly diabetes treatment, BYDUREON represents an important milestone in Amylin's promise to bring to market innovative therapies to help improve the lives of people with type 2 diabetes," said Daniel M.
"BYDUREON builds upon the proven benefits of BYETTA, offering significant improvements in glycemic control in a single weekly dose."
In the DURATION-5 head-to-head clinical study, after 24 weeks of treatment, 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 BYETTA.