Posted by Michael Wonder on 27 Jan 2023
Marketing authorisation application for lecanemab as treatment for early Alzheimer's disease accepted by EMA
27 January 2023 - Eisai and Biogen announced today that the EMA has accepted 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) with confirmed amyloid pathology, for review following a standard timeline.
In Japan, Eisai submitted a marketing authorisation application to the PMDA on 16 January 2023. In China, Eisai has initiated submission of data for a biologics license application to the NMPA of China in December 2022.
