MAA submitted to EMA for lecanemab as a treatment for early Alzheimer's disease
Eisai Co., Ltd. and Biogen Inc. announced that Eisai has submitted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: Leqembi), an investigational anti-amyloid beta (Abeta) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) to the European Medicines Agency (EMA)
This application is based on the results of the Phase III Clarity AD study and the Phase IIb clinical study (Study 201), 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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