Neurologist David Weisman, with financial ties to the companies, was removed from the FDA’s upcoming advisory committee meeting slated to consider Leqembi’s traditional approval.
Pictured: FDA sign in front of building/Adobe Stock/Grandbrothers
Monday, the FDA removed neurologist David Weisman from an upcoming Peripheral and Central Nervous System Drugs Advisory Committee meeting to discuss the full approval of Eisai’s and Biogen’s Alzheimer’s disease medicine Leqembi (lecanemab).
In April 2023, the regulator granted Weisman’s waiver, allowing him to participate in the meeting as a temporary voting member. The Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) is set to convene on June 9.
The waiver document listed Weisman’s conflicts of interest, including his role as a site principal investigator for a clinical trial sponsored by Biogen. The patient population in this study also overlaps with the indication to be discussed in the upcoming PCNS meeting. Weisman receives between $5,000 and $15,000 per year for his involvement in this study.
Weisman is also a site principal investigator for an Eisai-sponsored Phase II study of lecanemab, though this study is not up for deliberation at the advisory committee meeting. In this role, Weisman receives up to $5,000 in yearly salary.
Despite these financial conflicts, the FDA initially allowed his participation in the PCNS, citing his “unique qualifications and specialized expertise.”
In 2008, Weisman founded the Clinical Trial Center of Abington Neurological Associates, his employer, and has since run several clinical trials in Alzheimer’s disease and mild cognitive impairment.
“Any potential for a conflict of interest is greatly outweighed by the strong need for Dr. Weisman’s expertise in this matter,” the FDA stated in its waiver document.
However, in a tweet posted Monday, Weisman revealed that he was no longer on the panel “for entirely unrelated reasons,” though he did not explain exactly why he was pulled from the meeting.
Aside from his financial conflicts, Weisman was one of dozens of signatories of a May 2023 open letter from the Alzheimer’s Association urging the PCNS to back the full approval of Leqembi.
Leqembi Faces Adcomm
Biogen and Eisai won the FDA’s accelerated approval for Leqembi in January 2023, making it the second Alzheimer’s treatment to hit the market.
Its approval was based on Phase II data, which showed that the therapeutic antibody could significantly lower the accumulation of amyloid-β plaques in the brain. To demonstrate Leqembi’s clinical benefit, the pharma partners ran the Phase III Clarity-AD study, whose results demonstrated slower disease progression and better cognitive and functional performance among treated patients.
Clarity-AD will also serve as Leqembi’s confirmatory trial—a regulatory requirement to convert its accelerated approval into a full one—and will be scrutinized in the upcoming PCNS meeting. The FDA is expected to decide on Leqembi’s traditional approval by July 6.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
