The U.S. Food and Drug Administration has approved a supplemental Biologics License Application for a subcutaneous form of lecanemab, branded as LEQEMBI IQLIK, for the treatment of early Alzheimer's disease, Eisai Co., Ltd. and Biogen Inc. announced.
This approval introduces a once-weekly, at-home administration option via an autoinjector, offering a convenient alternative to intravenous dosing from the start of treatment. The regimen begins with a 500 mg initiation dose, delivered as two 250 mg injections. After 18 months of treatment, a maintenance dose of 360 mg weekly is available.
LEQEMBI is indicated for adults with mild cognitive impairment or mild dementia due to Alzheimer's disease. Clinical data from the Phase 3 Clarity AD long-term extension studies demonstrated that subcutaneous administration achieves exposure equivalent to intravenous dosing, with similar efficacy and safety profiles.
Howard Fillit, MD, Co-Founder and Chief Science Officer Emeritus of the Alzheimer's Drug Discovery Foundation, highlighted the significance of this development, noting the increased flexibility and choice it offers to patients and their care partners.
The subcutaneous option aims to reduce the burden of clinic visits, reliance on healthcare resources, and treatment preparation time, while preserving infusion capacity for those who prefer intravenous therapy. An autoinjector acceptability study reported high satisfaction and confidence levels among patients and care partners using the device at home.
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