For the first time, a drug proven to slow the progress of Alzheimer’s disease has received full approval from the Food and Drug Administration (FDA). This landmark move opens the door for its substantial cost to be covered by Medicare.
Earlier this year, Leqembi was granted Accelerated Approval by the FDA. Leqembi, a product of the Japanese pharmaceutical company Eisai, gives hope to individuals suffering from unmet medical needs. However, its cost was projected to be about US$26,500 per annum.
Leqembi, or lecanemab, is a revolutionary intravenous drug that slows the accumulation of sticky amyloid plaques that develop in the brain as Alzheimer’s disease advances. Its trials have shown impressive results, slowing the decline of memory and thinking capabilities by up to 27% in the early stage of the disease for patients with mild symptoms.
Administered via IV infusion twice monthly, Leqembi has the potential to positively change the lives of millions of American adults living with Alzheimer’s disease.
“This therapy, while not a cure, grants people with early-stage Alzheimer’s the gift of time: time to maintain their autonomy and engage in activities they enjoy,” says Joanne Pike, Alzheimer’s Association president and CEO. “This means more precious months of recognizing their spouse, children, and grandchildren. More time to drive safely, manage familial finances countlessly and to immerse fully in pastimes and interests.”
Despite groundbreaking results, Leqembi’s use has drawn attention due to potential serious side effects. 13% of the 1,795 participants in the clinical trial known as Study 301 experienced brain swelling or bleeding. The drug will need close monitoring through brain scans, and its use requires caution, particularly for people already on blood-thinning medications or those genetically predisposed to Alzheimer’s disease (homozygous for the ApoE ε4 allele).
However, the most common side effects include headaches, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA), typically presenting as temporary brain swelling that usually resolves over time.
“Today’s approval is a monumental breakthrough. It’s the first confirmation that a drug tackling the underlying disease process of Alzheimer’s has shown tangible benefits in this harrowing disease,” says Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Our study conclusively verifies Leqembi as a safe and effective treatment for patients living with Alzheimer’s disease.”
