FDA approves Bydureon

Long-awaited approval brings first once-weekly Type 2 diabetes drug to market in February

SAN DIEGO — The Food and Drug Administration has approved a long-acting injected diabetes drug made by Amylin Pharmaceuticals and Alkermes, the two companies said.

The FDA approved Bydureon (exenatide), which the companies called the first once-weekly treatment for Type 2 diabetes. The drug will become available in February.

"With Bydureon, U.S. physicians can now choose a therapy that offers continuous blood sugar control in just one dose per week," University of North Carolina in Chapel Hill professor of medicine John Buse said in a statement on behalf of the companies. "New treatment options are essential for the millions of adults with Type 2 diabetes who continue to struggle to achieve optimal blood-sugar control."

Bydureon, an extended-release formulation of Byetta, was originally developed under an alliance between Amylin and Eli Lilly that started in 2002, but the two companies terminated the alliance in November 2011 after Lilly formed a diabetes partnership with Boehringer Ingelheim. The Lilly-BI partnership prompted a lawsuit from Amylin, though the companies agreed to settle it.


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