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A treatment that may moderately slow mild cognitive decline and reduce amyloid-β plaques in patients with early Alzheimer disease gained accelerated approval from the US Food and Drug Administration (FDA).Lecanemab-irmb, marketed as Leqembi by Eisai and Biogen, is indicated for patients with mild cognitive impairment or mild dementia due to Alzheimer disease.In a clinical trial involving 1795 patients, those receiving lecanemab showed slower cognitive decline than those receiving a placebo after 18 months of treatment.In a substudy of 698 patients, those receiving lecanemab also showed greater reductions in amyloid-β plaques, which was the basis for the FDA's accelerated approval.Lecanemab's label warnings include the possibility of amyloid-related imaging abnormalities, such as edema or effusions, and infusion-related reactions.It is the second monoclonal antibody approved for Alzheimer disease.Continued approval may be subject to verification of clinical effect in a confirmatory trial.
Howard Larkin (Wed,) studied this question.