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Eisai submits MAA in UK for LEQEMBI® (lecanemab) for early Alzheimer’s

May 21, 2023

Biogen and Eisai announced that Eisai submitted a marketing authorisation application (MAA) for LEQEMBI® (lecanemab) to the UK Medicines and Healthcare products Regulatory Agency (MHRA).  LEQEMBI® is an investigational anti-amyloid beta protofibril antibody indicated for the treatment of early Alzheimer’s disease (AD) with confirmed amyloid pathology in the brain.  Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway.

Last week Health Canada accepted a new drug submission for LEQEMBI® to treat early AD and mild AD dementia with confirmed amyloid pathology in the brain.