Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) announced on Tuesday that its partner Eisai Co Ltd's (TYO:4523) Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing has been accepted by the US Food and Drug Administration (FDA).

Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease. It is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option. The Prescription Drug User Fee Act (PDUFA) action date has been set to 31 August 2025.

The BLA is based on data from the Clarity AD (Study 301) open-label extension and modelling of observed data. The SC-AI 360 mg weekly maintenance regimen will allow patients who have completed the biweekly intravenous (IV) initiation phase, exact period under discussion with the FDA, to receive weekly doses that are expected to maintain the clinical and biomarker benefits.

Leqembi is already approved in the United States, Japan, China, Great Britain and other markets. In November 2024 the treatment received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval.