Free Access To High-Cost Aducanumab May Incentivize Phase IV Trial Participants
Accelerated Approval Adds Another Alzheimer’s Study To Global Pipeline
Experts say there should be enough Alzheimer’s patients willing to enroll in Biogen/Eisai’s US FDA-required Phase IV trial and other companies’ late-stage studies even with Aduhelm broadly available.
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Biogen has warned that uptake for its newly approved Alzheimer’s therapy will be slow in the beginning and doctors confirm it will take time to figure which patients can and should be treated.
The co-founder of the Swiss company which discovered aducanumab looks back over its 20 year wait for approval, and ahead to future growth plans.
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.