Eisai Receives FDA Approval for LEQEMBI IQLIK Subcutaneous Injection for Early Alzheimer’s Initial Therapy

TOKYO, Jul 14 (Pulse News Wire) – Eisai CO.,LTD. (4523.T) announced that the U.S.

Food and Drug Administration (FDA) approved the subcutaneous injection formulation of LEQEMBI IQLIK (lecanemab) for initial therapy in patients with early Alzheimer’s disease. The weekly dose regimen was granted approval based on comprehensive clinical data from multiple trials evaluating various dosages of the antibody. LEQEMBI IQLIK is set to launch in the United States in late August 2026. The approval marks a significant advancement in patient care, offering greater convenience through home administration.

Clinical studies showed that the subcutaneous route provides equivalent exposure levels and benefits compared to intravenous administration, while maintaining a favorable safety profile. Patients and caregivers reported high satisfaction and confidence in using the auto-injector device. Eisai will continue to lead global development and regulatory filings for LEQEMBI, collaborating with Biogen on commercialization efforts. The companies aim to expand treatment options and support ongoing research in precision medicine and combination therapies.