Biogen, Eisai win full FDA approval for Alzheimer's drug Leqembi - InvestingChannel

Biogen, Eisai win full FDA approval for Alzheimer’s drug Leqembi

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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