FDA grants full approval to Lecanemab for the treatment of Alzheimer's

On July 6, the Food and Drug Administration granted full approval to LEQEMBI (lecanemab) for the treatment of Alzheimer's disease (AD). According to the current FDA approval, lecanemab should be initiated in patients with mild cognitive impairment or mild dementia. Lecanemab is the first approved treatment shown to slow down the progression of the disease, reduce cognitive decline, and improve daily functioning in adults with AD.

Lecanemab is now fully approved for treating individuals who already have cognitive impairment and mild dementia caused by AD. It had previously received accelerated approval based on its ability to reduce the accumulation of amyloid plaques in the brain, a significant characteristic of AD. Researchers studying Alzheimer's disease have found that early intervention may be crucial in combating the disease. Current studies are exploring whether lecanemab can effectively delay or prevent symptoms if administered before cognitive impairment becomes apparent.

The AHEAD Study is investigating the effects of lecanemab in individuals who show no signs of cognitive impairment but have biomarker tests indicating the presence of amyloid in the brain, a stage known as "preclinical" Alzheimer's disease. This study is the first of its kind to recruit individuals as young as 55 who are at risk of developing AD symptoms as they age. The AHEAD Study builds upon the positive outcomes observed in the Clarity AD Study, which focused on individuals with mild cognitive impairment or mild dementia.

"The benefits of lecanemab may be larger at this stage of the disease since there is less irreversible neurodegeneration." said Paul Aisen, M.D., founding director of Alzheimer's Therapeutic Research Institute.

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Research was supported by the NIH's National Institute on Aging under award numbers R01AG054029 and R01AG061848. The AHEAD Study (Clinical Trial number NCT04468659) received funding from NIH and from nongovernmental sources. The content is solely the responsibility of the researchers and does not necessarily represent the official views of the NIH.

This release discusses investigational uses of an agent and is not intended to convey conclusions about efficacy or safety. There is no guarantee that an agent will successfully complete clinical development or gain health authority approval.