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 extended by three months the review of the supplemental Biologics License Application for once-weekly subcutaneous lecanemab irmb injection, known as Leqembi Iqlik, for early Alzheimer's disease.

The FDA has set a new Prescription Drug User Fee Act action date of 24 August 2026, after requesting additional information that was classified as a major amendment to the application.

BioArctic said the FDA has not raised concerns regarding the approvability of Leqembi Iqlik as an initiation therapy.

Eisai believes that clinical data from multiple studies and dosing regimens support the potential use of the subcutaneous formulation, following FDA approval of the maintenance dosing regimen in August 2025.

Leqembi has received approvals from more than 50 regulatory authorities globally for the treatment of early Alzheimer's disease.

Leqembi was developed by BioArctic in collaboration with Eisai. The Japanese company is responsible for clinical development, marketing authorisation applications 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 currently preparing for a joint commercialisation in the region.