Bydureon Review Documents Paint An Unflattering Portrait Of Amylin
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Division of Metabolism and Endocrinology Products Director Mary Parks said the review of exenatide extended-release was delayed and complicated by the company’s withholding of important information about the QT effects of Byetta, an assertion the sponsor disputes. Amylin’s appeal of a second “complete response” letter failed to overturn the requirement for a new QT study pre-approval.