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A panel of independent advisors 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 get full approval.
The FDA is not required to follow the advisers’ 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. The agency’s decision will determine whether Medicare broadly covers the treatment. The seniors program is currently severely limiting Leqembi’s coverage as it was previously approved under an expedited process.
Leqembi is the second Alzheimer’s drug from Eisai and Biogen to be reviewed by the FDA, following the controversial approval of the drug Aduhelm in the summer of 2021.
The drug agency gave accelerated approval to the Aduhelm developed by the two companies, although 10 out of 11 members of the advisory committee concluded that the treatment showed no clinical benefit. A congressional investigation subsequently found that Aduhelm’s approval was “riddled with irregularities.”
FDA officials said in a briefing document ahead of Friday’s meeting that clinical trial data presented by Eisai appeared to confirm Leqembi’s clinical benefit for Alzheimer’s patients, suggesting the agency is poised to approve the treatment this summer to permit.
Leqembi slowed cognitive decline by 27% in early-stage Alzheimer’s patients in the study, but the treatment also carries serious risks of brain swelling and bleeding. The antibody is given twice monthly by intravenous infusion.
Small panel due to conflicts of interest
The Advisory Committee for Leqembi is unusually small, with only six voting members.
dr Teresa Buracchio, acting chief of the FDA’s neuroscience office, said the committee was smaller than usual because a number of experts withdrew from Friday’s meeting due to conflicts of interest.
“Although this group is small, it has the expertise needed to have an informed discussion on today’s topic,” Buracchio said.
Buracchio said the FDA’s decision on who to include in Friday’s meeting was influenced by a letter from the Alzheimer’s Association, in which it advocated full approval of Leqembi. At least one member of the FDA Advisory Committee, Dr. David Weisman, signed this letter.
Weisman was originally barred from attending Friday’s meeting despite serving as the principal investigator for Biogen and Eisai clinical trials on Leqembi and Aduhelm at Abington Neurological Associates.
Weisman then withdrew from the meeting and is not attending.
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The incumbent chairman Dr. Robert Alexander was granted an exemption from chairing the panel on Friday, despite holding up to $150,000 worth of stock in companies that compete with Eisai and Biogen. The companies’ names were not named in the FDA disclosure.
Alexander is the scientific director of the Alzheimer’s Prevention Initiative at Banner Alzheimer’s Institute. Banner conducts an Alzheimer’s clinical trial for a competing company, and Alexander earns between $50,000 and $100,000 a year from funding the study.
Bryan Marshall, who heads the office that manages FDA advisory committees, asked the agency to grant Alexander a waiver because he has unique expertise that was “invaluable” to Friday’s meeting.
Medicare coverage, price controversy
Leqembi is technically already available in the U.S. market after it received accelerated approval in January, but very few seniors have access to the expensive treatment because Medicare limits coverage only to people participating in clinical trials. There are no ongoing clinical trials.
As a result, most seniors only have access to Leqembi if they can afford to pay for the drug out of pocket. Leqembi has a list price of $26,500 per year.
Medicare has promised full coverage for Leqembi the same day the FDA fully approves the drug. The Veterans Health Administration already covers the cost of treating veterans.
Members of Congress and organizations advocating for Alzheimer’s patients will be following Friday’s Advisory Committee meeting closely.
Senator Bernie Sanders, chair of the Senate Health Committee, said the price for Leqembi was “outrageous” and in a letter to HHS Secretary Xavier Becerra ahead of the meeting, urged the Department of Health and Human Services to take action to bring the price down Week.
Sanders said in his letter Wednesday that “the FDA has a special responsibility to restore public confidence after forming an inappropriate relationship with Biogen during the agency’s review of a previous Alzheimer’s drug, Aduhelm.”