Monoclonal antibodies have emerged as a promising approach in the fight against Alzheimer’s disease, offering hope for slowing its progression. These laboratory-produced molecules are designed to target specific proteins associated with the disease, particularly amyloid-beta, which accumulates abnormally in the brains of Alzheimer’s patients.
Lecanemab, marketed as Leqembi, is one such antibody that has gained attention. Developed by Eisai and Biogen, it received accelerated approval from the U.S. Food and Drug Administration in January 2023, with full approval granted in July 2023. The drug is indicated for individuals with mild cognitive impairment or mild dementia due to Alzheimer’s. Clinical trials demonstrated that lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months.
Despite these advancements, access to lecanemab varies globally. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency approved the drug; however, the National Institute for Health and Care Excellence has not recommended it for National Health Service use, citing concerns over cost-effectiveness. Consequently, lecanemab is available only through private channels in the UK.
Another monoclonal antibody, aducanumab , also developed by Biogen, received accelerated approval from the FDA for early Alzheimer’s treatment. However, its approval has been met with controversy due to debates over its clinical efficacy and associated risks.
Donanemab, developed by Eli Lilly, is another promising monoclonal antibody targeting amyloid-beta. In a phase 3 randomized clinical trial, donanemab slowed clinical disease progression in amyloid-positive, early symptomatic Alzheimer’s patients over 76 weeks. The drug is currently under regulatory review, with decisions pending in various countries.
