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Eisai submits Marketing Authorisation Variation to EMA for intravenous maintenance dosing every four weeks with Leqembi® (lecanemab)
BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have 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.
About this update from Bioarctic Ab Class B
[{"type":"text","content":"STOCKHOLM, Sweden, Jan. 26, 2026 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have 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. ","length":348,"tagName":"p"},{"type":"text","content":"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[1]) non-carriers or heterozygotes with confirmed amyloid pathology.[2] 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.","length":762,"tagName":"p"},{"type":"text","content":"Lecanemab 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 clinical development, applications for market approval and commercialization of lecanemab for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region.","length":571,"tagName":"p"},{"type":"text","content":"This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below, on January 26, 2026, at 22:00 CET.","length":263,"tagName":"p"},{"type":"text","content":"For further information, please contact:","length":40,"tagName":"p"},{"type":"text","content":"Oskar Bosson, VP Communications and Investor RelationsE-mail: [email protected] Telephone: +46 70...