FDA advisers consider whether Alzheimer’s drug Leqembi should receive full approval

FDA advisers consider whether Alzheimer's drug Leqembi should receive full approval
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  • Independent advisors to the FDA will make a recommendation on whether Eisai and Biogen’s Alzheimer’s treatment, Leqembi, should receive full approval.
  • The FDA will make a final decision on Leqembi on July 6.
  • Medicare has promised to broadly cover Leqembi, which costs $26,500 a year, if the FDA grants full approval of the treatment.

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A group of independent advisers from the Food and Drug Administration will meet on Friday to make a recommendation on whether the Alzheimer’s drug Leqembi, made by Eisai and Biogen, should receive full approval from the agency.

The FDA is not required to follow the advisers’ recommendation, but a jury vote in favor of Leqembi would help pave the way for the treatment to be approved 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 undergo FDA review, following the controversial approval of the drug Aduhelm in the summer of 2021.

The medicines regulator granted accelerated approval to Aduhelm, developed by the two companies, despite 10 out of 11 advisory board members concluding that the treatment failed to demonstrate a clinical benefit. A congressional investigation later found that Aduhelm’s endorsement was “riddled with irregularities”.

Leqembi is technically already available on the U.S. market after receiving accelerated approval in January, but very few seniors can access the expensive treatment because Medicare is limiting coverage to only people participating in clinical trials. There are no ongoing clinical trials.

As a result, most older adults can only access 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 to broadly cover Leqembi the same day the FDA fully approves the drug. The Veterans Health Administration is already covering treatment for veterans. Members of Congress and organizations lobbying on behalf of Alzheimer’s patients are closely watching Friday’s advisory committee meeting.

FDA staff said the clinical trial data presented by Eisai appear to confirm Leqembi’s clinical benefit for Alzheimer’s patients, suggesting the agency is poised to approve the treatment this summer.

Leqembi slowed cognitive decline by 27% in patients with early Alzheimer’s, but the treatment also carries serious risks of brain swelling and bleeding. The antibody is given twice a month by intravenous infusion.

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The advisory board is unusually small, with only six voting members.

Interim chairman Dr. Robert Alexander won the waiver of leading the panel on Friday despite holding up to $150,000 worth of shares in companies that rival Eisai and Biogen. The FDA disclosure did not name the companies.

Alexander is the scientific director of the Alzheimer’s Prevention Initiative at Banner Alzheimer’s Institute. Banner is conducting an Alzheimer’s clinical trial for a competitor company, and Alexander receives a $50,000 to $100,000 salary annually from funding to support the trial.

Bryan Marshall, who heads the office that handles FDA advisory committees, asked the agency to give Alexander a waiver because he has unique expertise that is “invaluable” for Friday’s meeting.

Another committee member, Dr. David Weissman, will not attend Friday’s meeting, because he is the principal investigator for Biogen and Eisai’s clinical trials of Leqembi and another Alzheimer’s treatment called Aduhelm at Abington Neurological Associates.

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