FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease

Core Insights - LEQEMBI IQLIK is the first and only anti-amyloid treatment that allows for at-home injections, enabling patients and care partners to continue treatment after an initial 18-month intravenous therapy [1][2] - The U.S. FDA has approved the Biologics License Application for LEQEMBI IQLIK, which will be launched on October 6, 2025 [2][11] - The treatment is indicated for maintenance dosing in patients with mild cognitive impairment or mild dementia, following an initial 18-month intravenous treatment [2][16] Group 1: Treatment Mechanism and Efficacy - LEQEMBI targets both amyloid plaques and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease [4][12] - Clinical trials indicate that transitioning to the weekly LEQEMBI IQLIK autoinjector after 18 months maintains clinical and biomarker benefits comparable to continued intravenous dosing [5][40] - In the Clarity AD core study, treatment with lecanemab reduced clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) by 27% at 18 months compared to placebo [40] Group 2: Safety and Side Effects - The safety profile of LEQEMBI IQLIK is similar to that of intravenous treatment, with fewer systemic reactions reported [5][37] - Injection-related adverse events were less common with subcutaneous dosing, occurring in less than 1% of patients compared to approximately 26% with intravenous infusions [5][37] - The incidence of amyloid-related imaging abnormalities (ARIA) was similar between patients receiving the subcutaneous maintenance dose and those continuing with intravenous dosing [5][20] Group 3: Patient Support and Accessibility - Eisai offers various patient support programs in the U.S. to assist patients and care partners with treatment navigation and insurance coverage [9][10] - The Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost for eligible uninsured and underinsured patients [10] - The subcutaneous formulation is expected to reduce healthcare resource utilization associated with intravenous maintenance dosing, streamlining the overall Alzheimer's treatment pathway [8]