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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Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted with ‘due diligence.’
Survey of advisory committee members finds many believe an overwhelmingly negative vote should prevent a product approval. Survey was prompted by FDA accelerated approval of Alzheimer’s disease treatment Aduhelm despite overwhelming committee rejection.
Aduhelm Observational Study Will Spur Debate On Utility of Real-World Evidence For mABs In Alzheimer’s
Biogen’s ICARE AD-US study will assess the effects of aducanumab prescribed in routine practice to 6,000 patients. The lack of a concurrent control arm has critics questioning the study’s utility, but others say it could provide useful data on patient subgroups who were underrepresented or excluded from clinical trials and inform as to ARIA risks.