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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.

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