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Amylin Plans Cardiac Safety Study By The Book After Bydureon Rejection

Executive Summary

There’s more than meets the eye to the story of the seemingly surprising "complete response" letter for Amylin’s ultra-high-profile once-weekly diabetes injectable Bydureon.

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Bydureon Approval Provides Lesson In Clinical Data Requirements For Biosimilars

Changes in the manufacturing site and production scale for exenatide extended-release complicated FDA’s review of Bydureon, Amylin’s follow-on agent to Byetta, and late-rising questions about the drug’s QT effects made FDA revisit its earlier conclusion that the investigational and commercial formulations were comparable. The agency’s decision to require additional clinical data in a second “complete response” letter suggests biosimilar sponsors will face a similarly high clinical hurdle.

With Bydureon’s U.S. Approval, Amylin Extends Exenatide Franchise

Twice delayed by “complete response” letters, the drug’s approval gives Amylin a once-weekly GLP-1 analog, the longest-acting drug in its class.

Can Bydureon Bounce Back? Amylin's Proposed Cardio Safety Trial Is A Faster Option

If FDA approves the new protocol, a QT prolongation study required to refile Bydureon could commence this quarter.

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