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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Some Democratic senators are not fans of FDA’s approval of Biogen/Eisai’s Aduhelm, and are even more critical of the price of the Alzheimer’s therapy. That is providing a new hook to urge action on creating a federal price ‘negotiation’ program – but not any more clarity on a viable path to enacting one.
After three panel members resign over agency’s approval of Biogen’s Alzheimer’s disease drug, the ‘billion-dollar question’ is why FDA provided so little information to justify use of beta amyloid as a surrogate endpoint, one panelist asserts, especially since the agency expressly disavowed the pathway during the advisory committee meeting.
Study will assess responses of cancer survivors and caregivers to disclosures that a drug received accelerated approval. FDA analysis found that 73% of 26 accelerated approval drugs cited approval pathway on product websites.