Advisers to the U.S. Food and Drug Administration on Friday voted unanimously in favor of the Eisai Co. Ltd. and Biogen Alzheimer’s treatment Leqembi, saying that a clinical study had verified its benefit.
Leqembi, also known as lecanemab, is a monoclonal antibody designed to reduce the buildup of amyloid beta plaque in the brain, a hallmark of Alzheimer’s disease.
The treatment in January got a green light under the FDA’s accelerated approval program, which allows for earlier approval of drugs that treat serious conditions even while studies to confirm the anticipated clinical benefit are ongoing. If those trials show that the drug actually provides a clinical benefit, the FDA grants traditional approval for the drug. An FDA decision on traditional approval is expected by July 6. Advisory committee votes are not binding, but the FDA often follows committee recommendations.
About 6.7 million people 65 and older in the U.S. are living with Alzheimer’s dementia, according to the Alzheimer’s Association. Alzheimer’s was the fifth-leading cause of death among people 65 and older in 2019, according to the association.
Traditional approval of Leqembi, which has a sticker price of $26,500 per year, could have a significant impact on Medicare spending. If Leqembi and similar new Alzheimer’s treatments are granted traditional approval, the Centers for Medicare and Medicaid Services said last week that Medicare would cover the treatments in cases where the beneficiary’s doctor and clinical team participate in collecting real-world evidence about how the drugs are working — a system known as a registry.
If 5% of the older adults with Alzheimer’s disease take Leqembi, annual Medicare Part B spending would jump by about $8.9 billion, according to a recent analysis by health policy nonprofit KFF. The increased spending would likely lead to higher Part B premiums, according to the analysis.
During the open public hearing portion of the FDA meeting Friday, several experts raised concerns that the difference in cognitive outcomes for patients treated with Leqembi seemed small and emphasized safety issues identified in the clinical trials, including potential brain swelling or bleeding. “Patients and their families deserve better than false hope,” Patricia Bencivenga, special projects coordinator for PharmedOut, a research and education project at Georgetown University Medical Center, told the committee.
Other public commenters emphasized the value of any slowing in Alzheimer’s patients’ decline. “The additional time provided by these treatments is clear,” Joanne Pike, president and CEO of the Alzheimer’s Association, told the committee. “The value of this time is also clear when you listen directly to those who would benefit.”