Amylin Pharmaceuticals, Inc. and Alkermes plc received FDA approval for Bydureon, a next generation once-weekly
treatment for type 2 diabetes. The drug which received EU approval in June was turned down by the FDA twice during 2010, requesting further testing be conducted.
Bydureon, which is injected once a week, is due to replace Amylin’s twice daily Byetta and will compete against Novo Nordisk’s popular once daily, Victoza.
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. Bydureon uses Alkermes’ proprietary technology for long-acting medications to provide a controlled release of exenatide.
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. More information will be available atwww.BYDUREON.com.
Bydureon is provided in a straightforward single-dose tray so that patients can self-administer the once-weekly subcutaneous injection. Bydureon will be available in pharmacies nationwide in February.