Federal health regulators have approved Amylin Pharmaceutical's long-delayed diabetes drug Bydureon, a next-generation treatment that requires fewer injections than the company's current offering, Byetta.
The Food and Drug Administration approval comes after two previous rejections in 2010, when the agency asked Amylin to conduct a new study of the drug's effects on the heart. The agency has heightened its scrutiny of diabetes treatments since GlaxoSmithKline's diabetes pill Avandia was linked to heart attacks.
Bydureon is a once-a-week version of Byetta, which is taken twice a day to help diabetes patients control their blood sugar. Amylin executives say the new drug's convenient regimen will give it a competitive advantage in the marketplace. However, last year Amylin reported disappointing results for Bydureon against Novo Nordisk's Victoza, a once-daily injection approved last January.