The Food and Drug Administration converted Biogen (BIIB) and Eisai’s (ESALY) Leqembi, indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease, the agency said in a statement. The drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease, it added. Leqembi was approved in January under the accelerated approval pathway.
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