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Amylin, Alkermes Diabetes Drug Wins FDA Approval on Third Try

Amylin, Alkermes Diabetes Drug Wins FDA Approval

Jan. 27 (Bloomberg) -- Amylin Pharmaceuticals Inc. and Alkermes Plc succeeded in their third attempt to gain U.S. clearance for Bydureon, a once-weekly version of Amylin’s diabetes shot.

The Food and Drug Administration approved the drug for adults with Type 2 diabetes, the agency said today in a letter posted on their website.

Bydureon is a long-acting form of Byetta, a twice-daily shot that San Diego-based Amylin developed with Eli Lilly & Co. in a partnership that ended last year. Amylin lost almost half its market value on Oct. 20, 2010, after the FDA rejected Bydureon for a second time and sought a study on cardiac effects. The companies refiled for approval last year after the trial didn’t tie the drug to dangerous heart-rhythm changes.