Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) and its Japanese partner Eisai Co Ltd (TYO:4523) announced on Friday that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab subcutaneous injection for maintenance dosing.

The US brand name for the subcutaneous autoinjector is LEQEMBI IQLIK (pronounced 'I Click').

LEQEMBI IQLIK autoinjector is indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, collectively referred to as early AD, in the United States. After 18 months of Leqembi intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector.

LEQEMBI IQLIK will be launched on 6 October 2025.

Leqembi 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 the clinical development, applications for market approval and commercialisation of Leqembi for Alzheimer's disease. BioArctic has the right to commercialise Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialisation in the region.