Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) and its partner Eisai Co Ltd (TYO:4523) announced on Wednesday that the European Commission has granted marketing authorisation for Leqembi (lecanemab), marking the first EU-approved therapy targeting an underlying cause of Alzheimer's disease.

This approval entitles BioArctic to a milestone payment of EUR20m from Eisai.

Leqembi is indicated for adult patients with mild cognitive impairment or mild dementia due to Alzheimer's disease, specifically ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology. It is a monoclonal antibody designed to clear toxic Aβ protofibrils and reduce Aβ plaques in the brain.

The treatment addresses a significant unmet need, with early Alzheimer's disease affecting over 22 million people across Europe. Leqembi is expected to help slow disease progression and reduce societal burden.

Originally developed by BioArctic based on research by Professor Lars Lannfelt, Leqembi is now being commercialised globally by Eisai. In the Nordic region, BioArctic and Eisai will co-commercialise the therapy.

The centralised EU authorisation covers all member states, as well as Norway, Iceland and Liechtenstein. Leqembi is also approved in the United States, Japan, China, Great Britain and other markets.