Big Drug, Small Panel: US FDA Adcomm For Eisai/Biogen’s Leqembi Includes Only Six Voting Members
Six is the fewest number of voting experts for a drug or biologic advisory committee dating back to at least 2015, according to the Pink Sheet Performance Tracker. Agency issued two conflict-of-interest waivers for the meeting, one of which was to a site principal investigator on lecanemab and aducanumab studies but who is no longer participating in the Leqembi review.
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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.
The advisory committee convened to consider a traditional approval for Eisai/Biogen’s Alzheimer’s antibody Leqembi was the smallest in recent memory, with just six voting members. Yet, it worked surprisingly well. Is it time to rethink the size of FDA’s expert panels?
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.