BioArctic AB's (publ) (STO: BIOA B) partner Eisai announced  that the supplemental Biologics License Application (sBLA) for Leqembi Iqlik subcutaneous autoinjector (SC-AI) as a weekly starting dose has been granted Priority Review by the U.S. Food and Drug Administration (FDA). 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). A Prescription Drug User Fee Act (PDUFA) action date is set for May 24, 2026. If approved, Leqembi Iqlik would be the first and only anti-amyloid treatment to offer at-home injection options for initiation and maintenance dosing for this progressive, relentless disease.

Should the FDA approve the Leqembi Iqlik 500 mg subcutaneous (SC) dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once-weekly starting dose, as an alternative to the current bi-weekly intravenous (IV) dosing. This would enable patients and care partners to choose SC administration at home for both treatment initiation and the currently approved maintenance therapy (360 mg), offering the option of SC or IV administration throughout the entire treatment journey. The injection time for each Leqembi Iqlik autoinjector takes approximately 15 seconds per each 250 mg injection. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as infusion preparation and nurse monitoring, while streamlining the overall Alzheimer's disease treatment pathway.

The sBLA is supported by data evaluating SC administration of lecanemab across a range of doses and as part of sub-studies within the Phase 3 Clarity Alzheimer's disease open-label extension (OLE) following the 18-month core study in individuals with early Alzheimer's disease. Data show that once-weekly administration of the 500 mg of SC-AI achieved equivalent exposure to once every two weeks IV administration and similar clinical and biomarker benefits. SC administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection or infusion-related reactions.

Alzheimer's disease is a progressive, relentless disease, with amyloid beta (Aβ) and tau as hallmarks, that is caused by a continuous underlying neurotoxic process driven by protofibrils* (PF) that begins before amyloid plaque removal and continues afterward^[1],[2],[3]. Only Leqembi fights Alzheimer's disease in two ways – targeting both PF and amyloid plaque, which can impact tau downstream.