Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) announced on Monday that its Japanese partner Eisai Co Ltd (TYO:4523) has been granted Priority Review from the US Food and Drug Administration (FDA) for a supplemental Biologics License Application covering Leqembi Iqlik (lecanemab-irmb) subcutaneous autoinjector as a weekly starting dose.

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of 24 May 2026.

Leqembi is indicated for the treatment of Alzheimer's disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early Alzheimer's disease).

Approval would make Leqembi Iqlik the first anti-amyloid therapy offering at-home injection for both initiation and maintenance.

The application covers a 500 mg weekly subcutaneous regimen administered via two 250 mg injections, providing an alternative to bi-weekly intravenous dosing. Clinical data from Phase 3 Clarity Alzheimer's disease open-label extension studies showed equivalent exposure and similar clinical and biomarker outcomes versus intravenous administration, with a comparable safety profile and less than 2% incidence of systemic reactions.

Lecanemab, developed through a research alliance between BioArctic and Eisai, is approved in 53 countries and under regulatory review in seven more, with subcutaneous maintenance dosing already approved in the United States. The proposed subcutaneous initiation dosing could reduce reliance on infusion-related healthcare resources while offering patients greater flexibility throughout treatment.