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.
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Late recusal of several potential panelists was the result of a recent docket submission containing a December research community letter signed by dozens of Alzheimer’s experts, FDA said; signatories included neurologist David Weisman, who had received a conflict-of-interest waiver that cited his role in a Phase II lecanemab study but not in an ongoing Phase III study.
Two-and-a-half years after Aduhelm’s tumultuous advisory committee, FDA finally gets positive vote it was looking for, albeit on a different product. Leqembi meeting serves to endorse CDR-SB as clinical endpoint as well as amyloid plaque as surrogate for reduction in decline.
Reform efforts in CDER include ensuring expertise is specific to the issues being discussed, which may mean more temporary voting members on advisory committees.