11 January 2023 - Eisai and Biogen announced today that Eisai has submitted a marketing authorisation application for lecanemab, an investigational anti-amyloid beta protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer's disease dementia) to the EMA. 

This application is based on the results of the Phase 3 Clarity AD study and the Phase 2b clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early Alzheimer's disease, and is subject to a validation to determine whether the EMA accepts the application for review.

Read Eisai press release