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A group of independent consultants from the Food and Drug Administration are meeting on Friday to make a recommendation on whether the Alzheimer’s drug Leqembi, manufactured by come on And Biogenmust be fully approved.
The FDA is not required to follow advice from advisors, but the commission’s vote in favor of Lekambi will help pave the way for the treatment’s approval this summer. The FDA is expected to make a final decision on Lekambi on July 6th.
It is the second Alzheimer’s drug from Eisai and Biogen to pass FDA review following the controversial summer 2021 approval of Aduhelm.
The drug regulator gave fast-track approval to Aduhelm, developed by the two companies, despite 10 out of 11 advisory committee members finding the treatment had not shown clinical benefit. Subsequently, a congressional investigation found that Aduhelm’s approval was “rife with irregularities”.
Leqembi is technically already available in the US market after receiving accelerated approval in January, but very few older people can access the costly treatment as Medicare limits coverage to only people who participate in clinical trials. Clinical trials are not conducted.
As a result, most older people can only access Lekambi if they can afford to pay for the drug out of pocket. The list price of Leqembi is $26,500 per year.
Medicare has promised to cover Lekambi broadly the same day the FDA fully approves the drug. The Veterans Health Administration already covers veterans’ care. Members of Congress and Alzheimer’s patient lobbying groups are following Friday’s advisory committee meeting closely.
FDA officials said clinical trial data presented by Eisai appears to support Leqembi’s clinical benefit for Alzheimer’s patients, suggesting the agency is ready to approve the treatment this summer.
Lekambi slowed cognitive decline in patients with early-stage Alzheimer’s by 27% over the course of the study, but the treatment also comes with a serious risk of brain swelling and bleeding. The antibody is administered twice a month by intravenous infusion.
The Advisory Committee is unusually small, with only six voting members.
Dr. Teresa Buracchio, acting head of the FDA’s neurology division, said the committee is smaller than usual due to more experts pulling out of Friday’s meeting due to potential conflicts of interest.
“Despite the fact that this group is small, it has the relevant experience needed to fully discuss the topic under discussion today,” Buracchio said.
Committee member Dr. David Weisman, for example, is not attending Friday’s meeting because he is the principal investigator for clinical trials of Biogen and Eisai on Lekambi and another Alzheimer’s treatment called Aduhelm at Abington Neurological Associates.
Actor’s chair On Friday, Robert Alexander was given the right to lead the group despite owning up to $150,000 worth of shares in companies competing with Eisai and Biogen. The companies are not named in the FDA disclosure.
Alexander is the Chief Scientist of the Alzheimer’s Prevention Initiative at the Banner Alzheimer’s Institute. Banner runs an Alzheimer’s clinical trial for a rival firm, and Alexander receives $50,000 to $100,000 a year in salary from funding that supports the trials.
Brian Marshall, who heads the office that manages FDA advisory committees, asked the agency to grant Alexander a waiver because he has unique experience that is “invaluable” for Friday’s meeting.