Eisai submits marketing authorisation variation to EMA for intravenous maintenance dosing every four weeks with Leqembi (lecanemab)

BioArctic

26 January 2026 - BioArctic AB's partner Eisai announced today that they have submitted a proposed marketing authorisation variation to the EMA for a once every four weeks intravenous infusion maintenance dosing for lecanemab.

In the EU, lecanemab is indicated for the treatment of patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease (early Alzheimer's disease) who are apolipoprotein E ε4 non-carriers or heterozygotes with confirmed amyloid pathology.

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Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier , Registration