Bydureon Clinical Development
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A timeline chronicling the development history of Amylin’s exenatide extended-release.
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Bydureon Reviewers
FDA staff that participated in the review of Amylin’s diabetes drug exenatide LAR.
Bydureon Review Documents Paint An Unflattering Portrait Of Amylin
Division of Metabolism and Endocrinology Products Director Mary Parks said the review of exenatide extended-release was delayed and complicated by the company’s withholding of important information about the QT effects of Byetta, an assertion the sponsor disputes. Amylin’s appeal of a second “complete response” letter failed to overturn the requirement for a new QT study pre-approval.
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.