The U.S. Food and Drug Administration on Thursday granted full approval to the Biogen BIIB and Eisai Co. Ltd. ESALF Alzheimer’s treatment Leqembi, a step that secures Medicare reimbursement for the first drug shown to slow the progress of the disease, rather than just treating its symptoms. Leqembi, also known as lecanemab, is a monoclonal antibody designed to reduce the buildup of amyloid beta plaque in the brain, a marker of Alzheimer’s disease. In a late-stage trial, the treatment slowed declines in cognition and function by 27% compared with a placebo over 18 months. About 6.7 million people in the U.S. age 65 and older are living with Alzheimer’s–a number that could grow to 12.7 million by 2050, absent medical breakthroughs to prevent or cure the disease, according to the Alzheimer’s Association. Biogen stock, which was halted pending the news in the after-hours session, was down 0.3% on Thursday, while Eisai shares were up 1.2%.
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