Supplier News Breaks Archives
Amylin ships Bydureon in U.S.
February 13th, 2012
SAN DIEGO – Amylin Pharmaceuticals Inc. has released Bydureon, which it called the first and only once-weekly treatment for type 2 diabetes, to U.S. pharmacies.
Amylin said Monday that the Food and Drug Administration approved Bydureon (exenatide extended-release for injectable suspension) in late January as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Previously known as exenatide once weekly, Bydureon is a once-weekly formulation of exenatide, the active ingredient in Byetta (exenatide) injection, which has been available in the United States since June 2005 and is used in nearly 80 countries worldwide, according to Amylin.
Bydureon works with the body to help make its own insulin when needed, providing continuous glycemic control with just one dose per week. Using Alkermes PLC's proprietary technology for long-acting medications , the biodegradable microspheres in each dose of Bydureon provide a controlled release of exenatide throughout the week.
"Type 2 diabetes is a complex condition that can be very demanding for patients," stated Steven Edelman, M.D., professor of medicine in the division of endocrinology and metabolism at the University of California in San Diego. "I'm excited to be able to offer my patients Bydureon, since it provides significant improvements in blood glucose control with just one dose per week."