Modern Medical Laboratory Journal

The US Food and Drug Administration (FDA) has approved lecanemab, the second-ever treatment for Alzheimer’s disease intended to tackle the root of the condition and slow cognitive decline. Researchers welcome the decision, but the excitement is clouded by patient deaths and reports that the FDA acted improperly when approving the first such drug last year. Lecanemab, which will be sold under the brand name Leqembi, is the first Alzheimer’s treatment to slow cognitive decline in a robust clinical trial and the second to be approved in less than two years. It is made by the biopharmaceutical companies Eisai, in Tokyo, Japan, and Biogen in Cambridge, Massachusetts. The drug, a monoclonal antibody, is intravenously infused into patients, enters the brain and clears the amyloid plaques believed to cause cognitive impairment and dementia in Alzheimer’s. Lecanemab was authorized under the agency’s ‘accelerated approval’ pathway, which is reserved for therapies for diseases that have few treatments; it also does not require phase III clinical trial data. But researchers are hopeful about Biogen and Eisai’s phase III data, which were published in November 2022. That trial, conducted in about 1,800 people with early-stage Alzheimer’s, found that the antibody slowed cognitive decline by 27% over 18 months of treatment.
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