FDA Approves LEQEMBI IQLIK: First At-Home Injection for Early Alzheimer’s Maintenance Dosing
In a groundbreaking development for Alzheimer’s treatment, the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for LEQEMBI IQLIK (lecanemab-irmb), a subcutaneous injection designed for maintenance dosing in patients with early Alzheimer’s disease. Announced by Eisai Co., Ltd. and Biogen Inc., this marks the first anti-amyloid treatment offering an at-home injection option, set to launch in the U.S. on October 6, 2025. The approval provides a significant shift from the previous intravenous (IV) administration, offering patients and caregivers a more convenient and less invasive treatment pathway. LEQEMBI IQLIK, developed by Eisai, is a subcutaneous autoinjector delivering a 360 mg/1.8 mL dose (200 mg/mL) in approximately 15 seconds. It is intended for patients who have completed an initial 18-month IV treatment phase at 10 mg/kg every two weeks. Following this, patients can either continue with IV…

