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A panel of independent advisors to the Food and Drug Administration is meeting Friday to make a advice on whether the Alzheimer’s drug Leqembi, made by Eisai and Biogen, should receive full approval.
The FDA just isn’t required to follow the advisors’ advice, but a panel vote in favor of Leqembi would help pave the way in which for the treatment’s approval this summer.
The FDA is predicted to make a final decision on Leqembi on July 6. The agency’s decision will determine whether Medicare broadly covers the treatment. This system for seniors is severely restricting coverage of Leqembi immediately since it was previously approved through an expedited process.
Leqembi is the second Alzheimer’s treatment from Eisai and Biogen to come back under FDA review, after the controversial approval of the drug Aduhelm in the summertime of 2021.
The drug regulator granted expedited approval to Aduhelm, developed by the 2 firms, despite 10 out of 11 advisory committee members concluding that the treatment didn’t display a clinical profit. A congressional investigation subsequently found that the approval of Aduhelm was “rife with irregularities.”
FDA staff said in a briefing document ahead of Friday’s meeting that the clinical trial data submitted by Eisai appeared to verify the clinical advantage of Leqembi for Alzheimer’s patients, suggesting that the agency is poised to approve the treatment this summer.
Leqembi slowed cognitive decline in early Alzheimer’s patients by 27% within the trial, however the treatment also carries serious risks of brain swelling and bleeding. The antibody is run twice monthly through intravenous infusion.
Small panel attributable to conflicts of interest
The advisory committee for Leqembi is unusually small, with just six voting members.
Dr. Teresa Buracchio, acting head of the FDA’s neuroscience office, said the smaller-than-usual committee resulted from a variety of experts recusing themselves from Friday’s meeting attributable to conflicts of interest.
“While this group is small, it comprises the suitable expertise obligatory to have a strong discussion on the subject at issue today,” Buracchio said.
Buracchio said the FDA’s decision on whom to incorporate in Friday’s meeting was impacted by a letter from the Alzheimer’s Association that advocated for Leqembi’s full approval. At the very least one member of the FDA advisory committee, Dr. David Weisman, signed that letter.
Weisman was originally granted a waiver to take part in Friday’s meeting despite serving because the principal investigator for Biogen and Eisai clinical trials on Leqembi and Aduhelm at Abington Neurological Associates.
Weisman subsequently recused himself from the meeting and just isn’t participating.
Acting Chair Dr. Robert Alexander was granted a waiver to guide the panel Friday despite holding stocks valued as much as $150,000 in firms that compete with Eisai and Biogen. The FDA disclosure didn’t name the businesses.
Alexander is the chief scientific officer of the Alzheimer’s Prevention Initiative on 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 yr 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’s “invaluable” to Friday’s meeting.
Medicare coverage, price controversy
Leqembi is technically already available on the U.S. market after receiving fast-track approval in January, but only a few seniors can access the expensive treatment because Medicare is restricting coverage to only people who find themselves participating in clinical trials. There aren’t any clinical trials underway.
As consequence, most seniors can only access Leqembi in the event that they can afford to pay for the drug out of pocket. Leqembi has a listing price of $26,500 per yr.
Medicare has promised to broadly cover Leqembi on the identical day the FDA fully approves the drug. The Veterans Health Administration is already covering the treatment for veterans.
Members of Congress and organizations that lobby on behalf of Alzheimer’s patients are closely watching Friday’s advisory committee meeting.
Sen. Bernie Sanders, chair of the Senate Health Committee, said the value of Leqembi is “unconscionable” and called on the Health and Human Services Department to take motion to slash the value in a letter to HHS Secretary Xavier Becerra ahead of the meeting this week.
Sanders, in his letter Wednesday, said the “FDA has a special responsibility to revive the general public trust after its inappropriate relationship with Biogen throughout the agency’s review of a previous Alzheimer’s drug, Aduhelm.”
