BioArctic AB’s partner Eisai announced that the U.S. Food and Drug Administration has granted Priority Review for the supplemental Biologics License Application for Leqembi Iqlik, a subcutaneous autoinjector designed as a weekly starting dose for patients with early-stage Alzheimer’s disease. The Prescription Drug User Fee Act action date for the review is set for May 24, 2026. If approved, Leqembi Iqlik would become the first anti-amyloid therapy offering patients the option to start and maintain treatment at home through subcutaneous administration instead of the current bi-weekly intravenous infusion.
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The proposed dosing regimen involves two 250 mg injections for a total 500 mg weekly starting dose. Each injection takes approximately 15 seconds, allowing patients or caregivers to administer the treatment at home. The subcutaneous option is intended to reduce reliance on healthcare resources associated with IV dosing, such as infusion setup and nurse monitoring, while simplifying the treatment process for Alzheimer’s disease. Patients could continue with either subcutaneous or IV administration for ongoing maintenance therapy.
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The supplemental application is supported by clinical data from the Phase 3 Clarity Alzheimer’s disease open-label extension and its 18-month core study. Results show that once-weekly subcutaneous administration achieves drug exposure equivalent to bi-weekly intravenous dosing and provides similar clinical and biomarker benefits. Safety findings indicate that subcutaneous dosing has a profile comparable to IV administration, with less than 2 percent of patients experiencing systemic injection or infusion-related reactions.
Alzheimer’s disease is a progressive condition characterized by the accumulation of amyloid beta and tau proteins. The disease progresses through a continuous neurotoxic process driven by protofibrils, which begins before amyloid plaque forms and continues afterward. Leqembi is unique in targeting both protofibrils and amyloid plaques, potentially affecting downstream tau pathology and offering a dual approach to slowing disease progression.
Eisai emphasized that the subcutaneous formulation provides patients and caregivers with greater flexibility and convenience while maintaining the therapeutic benefits of intravenous dosing. This development represents a significant step toward making treatment for early Alzheimer’s disease more accessible and manageable in the home setting.
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