BioArctic AB has announced that its partner Eisai has submitted a proposed Marketing Authorisation Variation to the European Medicines Agency (EMA) for a once-every-four-weeks intravenous (IV) maintenance dosing regimen of lecanemab, an antibody therapy for early Alzheimer’s disease.

In the European Union, lecanemab is indicated for patients diagnosed with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology. The drug is currently approved as an IV infusion administered once every two weeks at a dose of 10 mg/kg.

According to Eisai’s submission, patients would initially continue the existing bi-weekly dosing regimen and transition to the proposed once-monthly maintenance dosing after 18 months of treatment. Lecanemab therapy is recommended to be discontinued once patients progress to moderate Alzheimer’s disease.

Lecanemab is the outcome of a long-standing collaboration between BioArctic and Eisai. The antibody was originally developed by BioArctic, building on research led by Professor Lars Lannfelt following the discovery of the Arctic mutation linked to Alzheimer’s disease.

Eisai leads the global clinical development, regulatory submissions and commercialisation of lecanemab for Alzheimer’s disease. BioArctic retains commercialization rights in the Nordic region, where the two companies are preparing for joint commercialization of the therapy.