Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial
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.
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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.
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.
Having a confirmatory trial underway at the time of approval should be the ‘default expectation’ and the agency should publicly explain when and why it grants exceptions to this rule, experts said at a National Academies meeting on accelerated approval.