Eisai Co., Ltd., headquartered in Tokyo with CEO Haruo Naito, and Biogen Inc., based in Cambridge, Massachusetts, with CEO Christopher A. Viehbacher, announced that Eisai has completed the rolling submission of the Supplemental Biologics License Application to the U.S. Food and Drug Administration for LEQEMBI IQLIK, the subcutaneous autoinjector form of lecanemab. The submission seeks approval for a weekly starting dose in patients with early Alzheimer’s disease, including those with mild cognitive impairment or mild dementia. The FDA has granted Fast Track Status for the application, and upon acceptance, will set a target date for review under the Prescription Drug User Fee Act.
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The submission is supported by data from sub-studies within the Phase 3 Clarity AD open-label extension that evaluated subcutaneous administration across multiple doses. Findings show that weekly 500 mg injections delivered through the autoinjector provide comparable exposure to the bi-weekly intravenous dose while maintaining similar clinical and biomarker outcomes. The safety profile for the subcutaneous form was consistent with intravenous dosing, with fewer than two percent of patients experiencing systemic injection or infusion reactions.
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If approved, LEQEMBI IQLIK could offer a convenient home-based treatment option, allowing patients and caregivers to choose between subcutaneous or intravenous administration for both the starting and maintenance phases. Each injection takes approximately 15 seconds, which may reduce the need for healthcare resources such as infusion preparation and monitoring, and streamline overall Alzheimer’s disease treatment. LEQEMBI targets both amyloid protofibrils and plaque, offering a dual mechanism to potentially slow disease progression.
LEQEMBI is currently approved in 51 countries and under review in nine additional regions. In August 2025, the FDA approved a 360 mg weekly subcutaneous maintenance dose following 18 months of bi-weekly intravenous treatment. Eisai leads global development and regulatory submissions, while Eisai and Biogen co-promote and co-commercialize the therapy with Eisai retaining final decision-making authority.
Protofibrils, the most toxic form of amyloid beta, are thought to drive cognitive decline in Alzheimer’s disease by damaging neurons and disrupting brain signaling. Reducing protofibrils may slow disease progression by preventing further neuronal injury. LEQEMBI is contraindicated in patients with known hypersensitivity to the drug or its components. Warnings include the risk of amyloid-related imaging abnormalities, which may present as brain edema or microhemorrhages and can cause headache, confusion, visual changes, dizziness, nausea, or gait disturbances. Symptomatic ARIA occurred in three percent of patients, serious ARIA in 0.7 percent, and intracerebral hemorrhage larger than one centimeter in 0.7 percent of patients. Most ARIA symptoms resolved over time during observation.
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