FDA approves Bydureon, first once-weekly treatment for type 2 diabetes

FDA has approved exenatide extended-release for injectable suspension (Bydureon, Amylin and Alkermes) - 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. It will be available in pharmacies nationwide in February.

“Bydureon ... offers significant improvements in efficacy and continuous glycemic control in a single weekly dose,” Alice Izzo, vice president of corporate affairs at Amylin, told Formulary. “Bydureon is continuously released throughout the week, helping to keep blood sugar levels under control.”

According to Izzo, Bydureon can help the body make its own insulin only at the times it’s needed. The drug also helps reduce food intake and it slows down how quickly food and sugar leave the stomach after a meal, she said. And the body will make less sugar at the right time.

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 1 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 United States since June 2005 and is used in nearly 80 countries worldwide.

Bydureon uses Alkermes’ proprietary technology for long-acting medications to provide a controlled release of exenatide.

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 A_1C of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for patients taking Byetta. A_1C is a measure of average blood sugar over 3 months.

Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 lb for patients taking Bydureon and 3.0 lb for patients taking Byetta (weight loss was a secondary end point). The most frequently reported adverse event in both groups was nausea, reported less frequently by Bydureon users (14%) than by Byetta users (35%). Other common treatment-emergent adverse events in the Bydureon group included diarrhea, upper respiratory tract infection, and injection-site nodules. There were no major hypoglycemic events.

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.

Bydureon is provided in a straightforward single-dose tray so that patients can self-administer the once-weekly subcutaneous injection. In the DURATION clinical studies, the delivery system was well accepted by patients and physicians.