Amylin Plans Cardiac Safety Study By The Book After Bydureon Rejection
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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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.
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.
If FDA approves the new protocol, a QT prolongation study required to refile Bydureon could commence this quarter.