By Allen Conrad
The U.S. Food and Drug Administration gave its approval to Amylin Pharmaceuticals and Alkermes for Bydureon, a next-generation once-a-week drug for type 2 diabetes.
The once-a-week injected Bydureon is slated to replace Amylin's twice daily Byetta, and it will also compete against Novo Nordisk's popular once-a-day Victoza. The drug, which was approved by the European Union last June, was turned down by the FDA twice during 2010, as the agency asked further testing to be conducted.
Bydureon's approval was based on safety and efficacy data from the DURATION clinical trial program, where treatment with Bydureon concluded in improvements in glycemic control with just once-a-week dosage. The federal agency also based its approval on clinical experience with Byetta (exenatide) injection, which is a twice-daily form of exenatide offered in the U.S. since June 2005. Bydureon uses Alkermes' proprietary technology to provide long-term medications for a controlled release of exenatide.
The FDA approved Bydureon with a Risk Evaluation and Mitigation Strategy (REMS) in order to make sure that the benefits of Bydureon outweigh the risk of acute pancreatitis and the risk of medullary thyroid carcinoma. As part of the REMS, Amylin has put in place a communication plan for healthcare professionals to help minimize the risks. Amylin will also fulfill several post-marketing requirements to analyze the effects of Bydureon on medullary thyroid cancer and cardiovascular conditions.
Bydureon is offered in a simple to use, single-dose tray so that patients can administer the once-weekly subcutaneous injection themselves. The drug will be available in pharmacies nationwide starting next month. For further information, log on to www.bydureon.com.
