Eisai (ESALY) and Biogen (BIIB) announced that an application for manufacturing and marketing approval for lecanemab, an anti-amyloid-beta protofibril antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare. Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened. In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency on January 16, 2023. 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.
Published first on TheFly
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