Global Courant
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A panel of independent advisors from the Food and Drug Administration will meet Friday to make a recommendation on whether the Alzheimer’s drug Leqembi, made by Eisai and biogenshould receive full approval.
The FDA is under no obligation to follow the advisors’ recommendation, but a panel vote in favor of Leqembi would 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. The agency’s decision will determine whether Medicare broadly covers the treatment. The senior program currently severely limits Leqembi’s coverage, as it was previously approved through an accelerated process.
Leqembi is Eisai and Biogen’s second Alzheimer’s treatment to come under FDA review, following the controversial approval of the drug Aduhelm in Summer 2021.
The drug regulator granted accelerated approval to Aduhelm, developed by the two companies, despite 10 of the 11 members of the advisory committee concluding that the treatment produced no clinical benefit. A congressional investigation subsequently found that Aduhelm’s endorsement was “riddled with irregularities”.
Senator Bernie Sanders, chair of the Senate Health Committee, told the Department of Health and Human Services in a letter Wednesday that the “FDA has a special responsibility to restore public trust following its improper relationship with Biogen during the review by the agency of a previous Alzheimer’s drug, Aduhelm.”
FDA sees clinical benefit, but there are risks
Eisai’s study of Leqembi found that the drug slowed cognitive decline in early Alzheimer’s patients by 27%. The antibody is administered twice a month by intravenous infusion. It targets a protein called amyloid, often called plaque, that builds up in the brain and is associated with the disease.
Dr. Teresa Buracchio, acting chief of the FDA’s neuroscience office, told the panel that the agency considers these results clinically meaningful to patients.
But Leqembi also carries serious risks of brain swelling and bleeding. During the study, 13% of patients receiving Leqembi had swelling and 14% had bleeding.
The swelling and bleeding are normally mild with no obvious symptoms, but these episodes can be life-threatening, according to the FDA.
There were three deaths in the study that may be related to Leqembi, although the FDA was unable to reach any definitive conclusions in its review.
Two deceased patients had cerebral hemorrhages after receiving the infusions. They had been given blood thinners. A third patient who died had an underlying condition called cerebral amyloid angiopathy, in which the blood vessels in the brain are weak, which can lead to bleeding.
Dr. Deniz Erten-Lyons, an FDA official, told the panel that taking blood thinners during Leqembi treatment could increase the risk of cerebral hemorrhage.
Small panel due to conflict of interest
The advisory committee for Leqembi is unusually small, with only six voting members.
Buracchio said the smaller-than-usual committee was a result of some experts pulling out of Friday’s meeting due to conflicts of interest.
“Although this group is small, it contains the appropriate expertise needed to have a robust discussion on today’s topic,” said Buracchio.
Buracchio said the FDA’s decision to include in Friday’s meeting was influenced by a letter from the FDA Alzheimer’s Association who argued for Leqembi’s full endorsement. At least one member of the FDA advisory committee, Dr. David Weisman, signed that letter.
Weisman was originally granted an exemption to attend Friday’s meeting despite being the principal investigator of the Biogen and Eisai clinical trials on Leqembi and Aduhelm at Abington Neurological Associates.
Weisman next turned down himself out of the meeting and does not participate.
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Acting Chairman Dr. Robert Alexander was waiver granted to lead the panel on Friday despite holding $150,000 worth of stock in companies competing 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 conducts an Alzheimer’s disease clinical trial for a competing company, and Alexander receives $50,000 to $100,000 in salary per year from funding to support the study.
Bryan Marshall, head of the agency that manages FDA advisory committees, asked the agency to grant Alexander a waiver because he has unique expertise that would be “invaluable” for Friday’s meeting.
Medicare coverage, pricing controversy
Leqembi is technically already available in the US market after accelerated access approval in January, but very few seniors have access to the expensive treatment because Medicare limits coverage to only people participating in clinical trials. No clinical trials are underway.
As a result, most seniors 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 pledged to broadly cover Leqembi the same day the FDA fully approves the drug. The Veterans Health Administration already covers treatment for veterans.
Members of Congress and organizations lobbying for Alzheimer’s patients are closely watching Friday’s advisory committee meeting.
Senate health committee chair Bernie Sanders said Leqembi’s price is “unconscionable” and called on HHS Secretary Xavier Becerra to take action to lower the price in a letter ahead of this week’s meeting.
Sanders said seniors would face significant out-of-pocket costs even if Medicare covered Leqembi. The price of the drug would also place a significant financial burden on the senior citizen program, driving up premiums even for people who don’t take the drug, he said.
(TagsToTranslate)Alzheimer’s Disease
