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...
Biogen Pulls EU Filing For Aduhelm But Stands By Alzheimer’s Drug
The marketing application was withdrawn before the European Medicines Agency had finished re-examining its earlier recommendation to reject the drug.
EU Aduhelm Filing: Biogen Faces Second High-Stakes Meeting At EMA
Biogen needs to explain why its Alzheimer’s disease drug should be approved in the EU, after the European Medicines Agency rejected the product last year.
Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate
Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.