Can Bydureon Bounce Back? Amylin's Proposed Cardio Safety Trial Is A Faster Option
This article was originally published in The Pink Sheet Daily
Executive Summary
If FDA approves the new protocol, a QT prolongation study required to refile Bydureon could commence this quarter.
You may also be interested in...
Amylin's Once-Weekly Bydureon Clears Major Cardiac Safety Hurdle
Extensive data on immediate and extended release exenatide can be "leveraged and applied" to speed development of a once-monthly injectable, which is ready for Phase III.
Amylin's Once-Weekly Bydureon Clears Major Cardiac Safety Hurdle
Extensive data on immediate and extended release exenatide can be "leveraged and applied" to speed development of a once-monthly injectable, which is ready for Phase III.
Amylin’s Once-Weekly Bydureon Clears Major Cardiac Safety Hurdle
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.