Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved LEQEMBI® IQLIK™ (lecanemab-irmb), a once-weekly subcutaneous autoinjector, for the maintenance treatment of early Alzheimer’s disease. The approval marks the first and only anti-amyloid therapy that offers patients an at-home injection option following 18 months of initiation with intravenous LEQEMBI. Commercial launch in the U.S. is planned for October 6, 2025.
Science Significance
LEQEMBI targets both amyloid plaques and toxic protofibrils, addressing Alzheimer’s pathology at multiple stages. Clinical trial data from the Phase 3 Clarity AD study and its open-label extension showed that subcutaneous dosing maintained clinical and biomarker benefits consistent with intravenous therapy. Importantly, systemic reactions were significantly reduced with the injection form, offering a safer and more patient-friendly long-term dosing option.
Regulatory Significance
This FDA approval, supported by robust efficacy and safety data in more than 600 patients, provides an alternative to infusion-center-based treatment. The decision underscores regulatory confidence in patient-managed delivery devices for complex biologics and supports broader treatment adherence through decentralized care models.
Business Significance
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The approval strengthens Eisai and Biogen’s co-commercialization strategy for LEQEMBI, expanding market potential by reducing infrastructure burdens on infusion centers. By offering both IV and SC options, the companies are positioned to capture a wider patient base while optimizing healthcare system resources. Eisai will lead regulatory and commercial execution globally, with Biogen as co-promoter.
Patients’ Significance
For patients and caregivers, LEQEMBI IQLIK represents a shift toward independence in Alzheimer’s management, reducing the need for frequent hospital visits. The device’s quick, 15-second administration makes treatment more accessible, potentially improving adherence and quality of life while helping patients “maintain who they are for longer.”
Policy Significance
This milestone supports policy priorities around patient-centric care and home-based therapeutic delivery, aligning with healthcare system goals to expand access, manage costs, and support rare and high-need disease populations. Patient support programs, including assistance for uninsured and underinsured patients, further reinforce accessibility.
Transaction Highlights
he European Medicines Agency (EMA) has granted five Orphan designations to MCO-010, covering a broad range of retinal dystrophies including rod-dominant, cone-dominant, syndromic, and macular dystrophies. In parallel, the U.S. FDA awarded Regenerative Medicine Advanced Therapy (RMAT) designation for Stargardt disease, building on prior Orphan Drug and Fast Track designations for both retinitis pigmentosa (RP) and Stargardt disease (SD). These regulatory milestones open accelerated pathways for clinical development and potential approvals, while also offering extended market exclusivity in both the U.S. and EU.
Backed by positive Phase 2b/3 RESTORE trial results in RP and encouraging Phase 2 STARLIGHT trial results in SD, Nanoscope is preparing to launch a Phase 3 registrational trial in SD and a Phase 2 trial in geographic atrophy (GA) by the end of 2025. Together, these advancements strengthen the company’s disease-agnostic MCO optogenetic platform, positioning it as a potential vision-restoring therapy with broad patient applicability.
Source: Eisai Inc.Press Release
