BioArctic AB (publ) and its partner Eisai announced that the U.S. FDA has approved the Biologics License Application (BLA) for LEQEMBI IQLIK, a once-weekly subcutaneous autoinjector for maintenance dosing in early Alzheimer’s disease (AD). The product will launch in the U.S. on October 6, 2025.
LEQEMBI IQLIK (pronounced “I Click”) is indicated for patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease. After completing 18 months of intravenous (IV) lecanemab at 10 mg/kg every two weeks, patients may continue with either IV infusion once every four weeks or the new 360 mg weekly subcutaneous injection.
Alzheimer’s disease is a progressive neurodegenerative condition marked by amyloid-β and tau pathology. Leqembi remains the only therapy targeting both amyloid plaque and protofibrils, which can influence downstream tau accumulation. Since biomarkers tend to re-accumulate when treatment is stopped, the new maintenance option is expected to help sustain therapeutic benefits and slow disease progression.
From a patient and caregiver perspective, the autoinjector offers at-home use, reduced treatment time, and fewer infusion center visits. For healthcare systems, it may ease resource demands by lowering infusion preparation and monitoring needs while freeing capacity for new patients to start therapy.
Leqembi is the product of a longstanding BioArctic–Eisai collaboration, originally based on the discovery of the Arctic mutation by Professor Lars Lannfelt. Eisai leads global development and commercialization, while BioArctic retains rights in the Nordic region, where both companies are preparing for a joint launch.