FDA approves once-weekly treatment for type 2 diabetes
Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist and works with the body to help make its own insulin. It is meant as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings. Bydureon, which uses Alkermes’ proprietary technology for long-acting medications to provide controlled release, will be available in pharmacies nationwide this February.
The approval of Bydureon 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. since June 2005 and is used in nearly 80 countries worldwide.
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. A1C is a measure of average blood sugar over three months.
Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking Bydureon and 3.0 pounds for patients taking Byetta (weight loss was a secondary endpoint).The most frequently reported adverse event in both groups was nausea, reported less frequently by Bydureon users (14%) than by Byetta users (35%).
Bydureon has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of Bydureon outweigh the risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma. As part of the REMS, Amylin has established a communication plan for healthcare professionals to help minimize these risks. In addition, Amylin will fulfill a number of post-marketing requirements to further assess the impact of Bydureon on medullary thyroid cancer and cardiovascular disease.