The first Alzheimer’s disease medication shown in trials to slow progression of the disease has been given full approval by the Food and Drug Administration (FDA), paving the way for its costly price tag to be covered by Medicare.
In January, Leqembi, from Japanese pharmaceutical company Eisai, was granted Accelerated Approval from the FDA, which is available for drugs that provide an unmet medical need, but the cost was expected to be around US$26,500 per year.
Leqembi, the brand name of lecanemab, is a intravenous drug that works by reducing the sticky amyloid plaques that form in the brain as Alzheimer’s disease progresses. In trials, it showed significant results in slowing the rate of memory and thinking decline by up to 27% for those with mild symptoms in the early stages of the disease.
An antibody, Leqembi is administered via IV infusion twice monthly and stands to benefit many of the more than six million American adults with Alzheimer’s disease.
“This treatment, while not a cure, can give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love,” said Joanne Pike, Alzheimer's Association president and CEO. “This gives people more months of recognizing their spouse, children and grandchildren. This also means more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests.”
But the drug comes with some potentially very serious side-effects. Around 13% of the 1,795 participants in the clinical trial known as Study 301 experienced brain swelling or bleeding. Leqembi requires monitoring with brain scans and is riskier for people who are also taking blood-thinning medications or are genetically predisposed to developing Alzheimer’s disease (homozygous for the ApoE ε4 allele).
However, the most common side effects are headaches and infusion-related reactions. Amyloid-related imaging abnormalities (ARIA) also occur, which most commonly presents as temporary swelling in regions of the brain and usually resolve in time.
“Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease,” said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
Source: FDA