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A panel of independent advisers to the Food and Drug Administration is meeting Friday to make a recommendation on whether the Alzheimer’s drug Leqembi, made by Eisai and Biogenicshould receive full approval.
The FDA is not required to follow the advisers̵[ads1]7; recommendation, but a panel vote in favor of Leqembi would help pave the way for the treatment’s approval this summer. The FDA is expected to make a final decision on Leqembi on July 6.
It is the second Alzheimer’s treatment from Eisai and Biogen to come under FDA review, following the controversial approval of the drug Aduhelm in the summer of 2021.
The medicines regulator granted fast-track approval to Aduhelm, developed by the two companies, despite 10 out of 11 advisory committee members concluding that the treatment did not show a clinical benefit. A congressional investigation later found that the approval of Aduhelm was “fraught with irregularities.”
Leqembi is technically already available on the US market after receiving fast-track approval in January, but very few seniors can access the expensive treatment because Medicare limits coverage to only people participating in clinical trials. There are no ongoing clinical trials.
As a consequence, most elderly people can only access Leqembi if they can afford to pay for the drug. Leqembi has a list price of $26,500 per year.
Medicare has promised to broadly cover Leqembi the day the FDA fully approves the drug. The Veterans Health Administration already covers the treatment for veterans. Members of Congress and organizations that lobby on behalf of Alzheimer’s patients are paying close attention to Friday’s advisory committee meeting.
FDA officials said the clinical trial data submitted by Eisai appeared to confirm the clinical benefit of Leqembi for Alzheimer’s patients, suggesting the agency is poised to approve the treatment this summer.
Leqembi slowed cognitive decline in early Alzheimer’s patients by 27% in the study, but the treatment also carries a serious risk of brain swelling and bleeding. The antibody is administered twice monthly through intravenous infusion.
The advisory committee is unusually small, with only six voting members.
Dr. Teresa Buracchio, acting director of the FDA’s Office of Neuroscience, said the smaller-than-usual committee was due to a larger number of experts withdrawing from Friday’s meeting because of potential conflicts of interest.
“While this group is small, it contains the necessary expertise to have a robust discussion on the topic today,” Buracchio said.
Committee member Dr. David Weisman, for example, is not participating in Friday’s meeting because he is the principal investigator for the Biogen and Eisai clinical trials on Leqembi and another Alzheimer’s treatment called Aduhelm at Abington Neurological Associates.
Acting chairman Dr Robert Alexander was given a dispensation to chair the panel on Friday despite holding shares worth up to $150,000 in companies that compete with Eisai and Biogen. The FDA disclosure did not name the companies.
Alexander is the Chief Scientific Officer of the Alzheimer’s Prevention Initiative at the Banner Alzheimer’s Institute. Banner is conducting an Alzheimer’s clinical trial for a competing firm, and Alexander receives $50,000 to $100,000 in salary per year from funding supporting the trial.
Bryan Marshall, who heads the office that manages the FDA’s advisory committees, asked the agency to grant Alexander a waiver because he has unique expertise that is “invaluable” for Friday’s meeting.