Amylin, Alkermes get OK for diabetes drug

WASHINGTON - Amylin Pharmaceuticals won approval yesterday for its long-delayed diabetes drug Bydureon, a next-generation treatment that requires fewer injections than the company’s 7-year old diabetes medicine, Byetta.

Bydureon is a once-a-week version of Byetta, which is taken twice a day to control blood sugar. Amylin executives say the drug’s convenient regimen will give it a competitive advantage. However, after multiple delays it enters a crowded market, including one diabetes treatment in the same class that has shown superior results.

The Food and Drug Administration approval comes after two rejections in 2010, when the agency asked Amylin to conduct a new study of the drug’s effects on the heart.


Bydureon was codeveloped with Eli Lilly, which also helped comarket Byetta. Both drugs are scheduled to transfer to Amylin by the end of 2013. Alkermes, based in Waltham, Mass., created Bydureon’s formulation technology, which gradually releases the drug over the course of a week.