Amylin’s Once-Weekly Bydureon Clears Major Cardiac Safety Hurdle
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Amylin and partners Eli Lilly and Alkermes plan to resubmit an application for once-weekly subcutaneous injectable Bydureon (exenatide) to FDA in the third quarter, after the candidate met the primary endpoint in a “thorough" QT study assessing cardiovascular risk, which is required for approval in the U.S.