BioArctic AB's partner Eisai has announced that it has submitted a proposed Marketing Authorisation Variation to the European Medicines Agency (EMA) for a once every four weeks intravenous (IV) infusion maintenance dosing for lecanemab.
In the EU, lecanemab is indicated for the treatment of patients with a clinical diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (early Alzheimer's disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology.
Lecanemab is the result of a strategic research alliance between BioArctic and Eisai.
It is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).
Lecanemab is currently licensed as an IV infusion with a dosing regimen of once every two weeks (10 mg/kg).
Eisai's submission states that following the initial dosing regimen of once every two weeks, after 18 months, patients will be transitioned to the maintenance dosing regimen of once every four weeks.
Treatment with lecanemab should be discontinued once the patient progresses to moderate Alzheimer's disease.
Eisai is responsible for clinical development, applications for market approval and commercialisation of lecanemab for Alzheimer's disease.
BioArctic has the right to commercialise lecanemab in the Nordic region together with Eisai and the two companies are preparing for a joint commercialisation in the region.