FDA takes action to grant traditional approval of Leqembi™ (lecanemab, Eisai/Biogen) for the treatment of early Alzheimer’s disease with confirmation of elevated amyloid beta. This is the first traditional approval of an Alzheimer’s treatment that changes the underlying course of the disease.

This treatment gives people in the early stages of Alzheimer’s disease more time to maintain their independence and do the things they love. Leqembi works by targeting amyloid beta, the primary component of amyloid plaques, which are a disease-defining hallmark in the brains of people with Alzheimer’s disease. Well-conducted clinical trials clearly demonstrate that removing amyloid from the brain provides measurable, meaningful benefit in people with early Alzheimer’s. In a Phase 3 clinical trial, Leqembi delayed cognitive decline by 5.3 months compared to placebo after 18 months of treatment, at a time when such delays are most valuable to the individual. Further delays in progression are anticipated with extended time under treatment. It is administered twice monthly through intravenous infusion. Leqembi has been on the market since January 2023, when it received accelerated approval from the FDA. However, to this point access has been blocked by Medicare coverage policies.

With this approval, early detection and diagnosis are even more critical to ensure individuals receive the most benefit at the earliest point possible. If you or a loved one is experiencing memory changes, the Alzheimer’s Association strongly encourages speaking with a health care provider for a thorough evaluation and diagnosis and to discuss treatment options. For more information visit alz.org.

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