Aduhelm Approval Firestorm Raises Question: What Are US FDA Advisory Committees For, Anyway?
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.
You may also be interested in...
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.
Agency officials are considering developing policies for when an advisory committee meeting is appropriate, in part because of the workload associated with them. Could fewer meetings result?
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.