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FDA approves exenatide extended-release for injectable suspension in type 2 diabetes
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Amylin Pharmaceuticals, Inc. and Alkermes PLC announced that the FDA has approved exenatide extended-release for injectable suspension, a once-weekly treatment for patients with type 2 diabetes. The treatment will be available nationwide beginning in February.
The glucagon-like peptide-1 receptor agonist is indicated as an adjunct to diet and exercise for improved glycemic control, according to a company press release.
Approval is based on data from DURATION-5, a head-to-head study that demonstrated that after 24 weeks of treatment, patients experienced a statistically significant reduction in HbA1c of 1.6 percentage points. The study compared once-weekly treatment with exenatide extended-release for injectable suspension (Bydureon) with twice-daily treatment with exenatide injection (Byetta).
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Both treatment groups achieved statistically significant weight loss at the study’s end, with an average loss of 5.1 lb for patients taking Bydureon and 3 lb for those taking Byetta. Nausea was the most commonly reported side effect in both groups, but occurred less often in the Bydureon group (14% vs. 35% for Byetta).
The once-weekly treatment is approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits outweigh the risk for acute pancreatitis and the potential risk for medullary thyroid carcinoma. Amylin has established a communication plan for health care professionals to help minimize these risks as part of the REMS. Additionally, the company will complete post-marketing requirements to further assess the effect of Bydureon on medullary thyroid cancer and cardiovascular disease, according to the press release.
In November 2011, Amylin and Eli Lilly and Company announced an agreement to terminate their alliance for exenatide and resolve the outstanding litigation between the two companies, according to a press release. At this time, full responsibility for the worldwide development and commercialization of exenatide was granted to Amylin.
“With Bydureon, US physicians and patients can now choose a therapy that offers continuous blood sugar control in just one dose per week,” John Buse, MD, PhD, 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, said in a press release. “New treatment options are essential for the millions of adults with type 2 diabetes who continue to struggle to achieve optimal blood sugar control.”
Disclosure: Dr. Buse is an investigator, consultant or both without any direct financial benefit to him under contracts between his employer and Amylin.
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