Can Bydureon Bounce Back? Amylin’s Proposed Cardio Safety Trial Is A Faster Option
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Amylin Pharmaceuticals Inc. confirmed that it is awaiting word from FDA regarding a proposed trial design for a cardiac safety study that involves a continuous infusion of exenatide. Amylin needs the study in order to resubmit the NDA for its once-weekly subcutaneous injectable Bydureon (long-acting exenatide), which it plans to do by year-end.