BioArctic : Marketing Authorization Application For Lecanemab Submitted In Great Britain

(RTTNews) - BioArctic AB's partner Eisai said that they have submitted a Marketing Authorisation Application for lecanemab, an investigational anti-amyloid beta (Aß) protofibril antibody, for the treatment of early Alzheimer's disease (AD) with confirmed amyloid pathology in the brain, to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.

Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.