Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial
Executive Summary
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.
You may also be interested in...
US FDA Neuroscience Office In Spotlight With Donanemab Delay, Relyvrio Trial Failure
Lilly’s surprise announcement that the Alzheimer’s drug is going to an advisory committee, followed minutes later by Amylyx’s disclosure that its ALS drug failed a Phase III study, marked a one-two punch of bad news for the Office of Neurosciences’ recent use of regulatory flexibility.
Aduhelm’s Goodbye: ENVISION Confirmatory Study To End In May, With BLA Withdrawal In November
Biogen faces complex logistics in shutting down a multinational trial with more than 200 sites and approximately 1,000 patients enrolled; company also is facing calls to publish data collected from the unfinished study as well as other aducanumab trials.
US FDA Neuroscience Office Director Billy Dunn Departs As Agency Faces New Review Challenges
Dunn is retiring after an 18-year career that included involvement in some high-profile and controversial drug approval decisions, not the least of which is Biogen’s Alzheimer’s treatment Aduhelm; deputy director Teresa Buracchio takes over the neurology office on an acting basis.