BioArctic AB’s partner Eisai has announced that the European Commission (EC) has decided to refer the marketing authorisation approval decision of lecanemab – an Alzheimer’s treatment – in the EU to the Appeal Committee.
The final process for the EC decision on lecanemab’s Marketing Authorisation Application (MAA) is underway, following the reconfirmation of the positive opinion for lecanemab’s approval by the Committee for Medicinal Products for Human Use (CHMP) in February 2025.
The EC announced that it has deliberated on the MAA in its Standing Committee and, based on the results of those deliberations, has referred the decision to the Appeal Committee in accordance with the EC review process.
If the marketing authorization application for lecanemab is approved, the approval will apply to all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway. Leqembi is already approved in the US, Japan, China, Great Britain and other markets.
Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer’s disease.
Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer’s disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and currently, the two companies are preparing for a joint commercialization in the region.
