Eisai (ESALY) and Biogen (BIIB) announced that Eisai has submitted a marketing authorization application for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early Alzheimer’s disease to the European Medicines Agency. This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study, which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD and is subject to a validation to determine whether the EMA accepts the application for review.
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