The US drug regulator has granted full approval to a new Alzheimer’s medicine, Leqembi, making it more widely available to the public through government-run health insurance for the elderly. Developed jointly by Japan’s Eisai and Biogen of the United States, Leqembi demonstrated modest reductions in cognitive decline during clinical trials for patients in the early stages of the disease. However, the study also raised concerns about potential side effects, including brain bleeds and swelling.
Drug regulator grants full approval, expanding accessibility but raising concerns
Leqembi was initially granted “accelerated approval” by the Food and Drug Administration (FDA) in January, limiting its coverage under the government-run Medicare program for individuals aged 65 and older. The recent decision, following further study of the drug, means that Medicare will now provide substantial coverage for Leqembi treatment, initially priced at $26,500 per year by the manufacturers.
The FDA’s decision was based on a confirmatory study that verified Leqembi as a safe and effective treatment for patients with Alzheimer’s disease. Teresa Buracchio, a senior FDA official, stated that the study provided evidence supporting its use. Chiquita Brooks-LaSure, the administrator of the agency overseeing Medicare, described the decision as welcome news for the millions affected by the debilitating disease.
While Medicare will cover a significant portion of the treatment cost, individuals covered by the program will still need to bear 20 percent of the expense, which could amount to thousands of dollars. This cost-sharing requirement may pose financial challenges for patients and their families.
Approximately 6.5 million Americans suffer from Alzheimer’s disease, a condition characterized by memory loss and declining mental acuity. Leqembi, also known as lecanemab, is an antibody treatment administered through brain injections every two weeks. It works by reducing amyloid beta, a protein that forms plaques and leads to the death of brain cells and brain shrinkage.
Patient advocacy groups have welcomed the FDA’s decision, recognizing that Leqembi, while not a cure, can provide individuals in the early stages of Alzheimer’s with additional time to maintain their independence and engage in activities they love. Joanne Pike, President, and CEO of the Alzheimer’s Association, emphasized the importance of granting patients more months of recognizing their loved ones.
Leqembi is the second Alzheimer’s drug developed by Eisai and Biogen to receive approval. The first drug, Aduhelm, was approved in 2021, but the decision was highly controversial due to inconsistent data regarding its efficacy. In May, US drugmaker Eli Lilly announced positive results for its Alzheimer’s drug, donanemab, which significantly slowed cognitive decline. The company intends to seek regulatory approval worldwide.
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Alzheimer’s Disease and its Impact
Alzheimer’s disease accounts for 60 to 80 percent of dementia cases, according to the Alzheimer’s Association. It progressively impairs thinking and memory, eventually robbing individuals of their ability to carry out basic tasks.
The full approval of Leqembi by the US drug regulator represents a significant development in the treatment of Alzheimer’s disease. While expanding accessibility, concerns about potential side effects, including brain bleeds and swelling, have been raised. The decision offers hope for individuals in the early stages of the disease, providing them with additional time to maintain their independence and cherished connections. As research continues, further advancements are expected in the fight against Alzheimer’s, offering improved treatments and support for patients and their families.
