Bydureon Sent Back to FDA

Xconomy San Diego — 

San Diego-based Amylin Pharmaceuticals (NASDAQ: AMLN), Indianapolis-based Eli Lilly (NYSE: LLY), and Waltham, MA-based Alkermes (NASDAQ: ALKS) said today that they have re-submitted an application to the FDA, for clearance to start marketing exenatide once-weekly (Bydureon) as a new treatment for diabetes in the U.S. The agency turned down an earlier application, asking the companies to produce more data showing the drug doesn’t have an effect on abnormal heart rhythms known as the QT interval. The new application includes such a study, which the companies reported on earlier this month. The FDA will likely have six months to complete its review of the application, the companies said. If approved, analysts expect the drug could generate billions in annual U.S. sales.