Bydureon regulatory update

FDA approved once-weekly Bydureon exenatide from Amylin to treat Type II diabetes. The drug will be available in February to wholesalers at a price of $323.44 for a pack of 4, single-dosing trays. That translates to a yearly price of about $4,200. The label includes a boxed warning about the potential risk of thyroid C cell tumors, including medullary thyroid carcinoma (MTC), which were seen at clinically relevant exposures in rats. The warning also notes that Bydureon is contraindicated in patients with a history of MTC or in patients with multiple endocrine neoplasia syndrome type 2. FDA approved a REMS that warns about the risks of acute pancreatitis and the potential risk of MTC. Bydureon is not recommended as first-line therapy for patients inadequately controlled on diet and exercise.

The approval comes nearly 3 years after Amylin submitted the NDA in 2009. FDA requested more information in complete responses in March and October of 2010, the most recent of which required a thorough QT study of Bydureon. Amylin completed the study last July. ...