Eisai submits Marketing Authorisation Variation to EMA for intravenous maintenance dosing every four weeks with Leqembi® (lecanemab)
BioAge Labs, Inc. (BIOA)
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Source: PR Newswire
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. 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 e4 (ApoE e4[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 pati
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