Swedish biopharma company BioArctic AB (STO:BIOA-B) and its Japanese partner Eisai (TYO:4523) announced on Thursday a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation application (MAA) for lecanemab in Alzheimer's disease.

This recommendation applies to the treatment of early Alzheimer's disease in adult patients that are apolipoprotein E Epsilon 4 (ApoE Epsilon 4) heterozygotes or non-carriers. It follows Eisai's request for a re-examination of the CHMP's earlier negative recommendation.

The European Commission is expected to take a decision on lecanemab within 67 days. The product is already approved in the United States, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates and Great Britain.

BioArctic has a long-term collaboration with Eisai for the development and commercialisation of drugs for the treatment of Alzheimer's disease. Under this agreement Eisai is responsible for the clinical development, applications for market approval and commercialisation of lecanemab for Alzheimer's disease. BioArctic has the rights to commercialise lecanemab in the Nordic region. Currently, BioArctic and Eisai are preparing for joint commercialisation in these countries, pending approval from the European Commission.