Eisai and Biogen announced that Eisai filed a marketing authorisation application (MAA) for LEQEMBI® (lecanemab) for treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain. The submission for the investigational anti-amyloid beta antibody was made to the Ministry of Food and Drug Safety in South Korea based on positive results from Phase III and Phase IIb studies
Eisai submitted an MAA to the MHRA in the UK for LEQEMBI® only a few weeks ago.