Eisai (ESALY) and Biogen (BIIB) announced that Eisai has initiated submission of data for Biologics License Application to the National Medical Products Administration of China for lecanemab, an investigational anti-amyloid beta protofibril antibody. The registration category of lecanemab was designated as a Category 1 drug. The data submitted in this package includes data from the Phase II clinical trial in mild cognitive impairment due to Alzheimer’s disease and mild AD with confirmed Abeta accumulation in the brain and the top-line data of the large global Phase III Clarity AD study. Eisai will submit additional data including full data of the Clarity AD study, as directed by the NMPA.
Published first on TheFly
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