FDA Approves LEQEMBI (LECANEMAB-IRMB) IV Maintenance Dosing for Early Alzheimer’s Disease: A New Milestone in Treatment Accessibility

Published: 28 Jan 2025

Author: Precedence Research

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Eisai and Biogen have won supplemental approval from the US Food and Drug Administration for a maintenance dosing regimen for the early stages of Alzheimer's disease through intravenous infusion with LEQEMBI®. This is important because it provides serious progress in AD therapy, making the administration of a patient's medication more manageable, taking full benefit of the therapy while at the same time making it available to any caregivers who might make it work. The maintenance dosing with LEQEMBI requires one dose every month, to commence just after an 18-month initiation phase of PRN dosing, with 10mg/kg given bi-weekly to mild cognitive impairment or mild dementia due to early Alzheimer's disease. 

This two-week dosing is designed to make treatment more accessible and cost-effective for the patient. FDA approval results from extensive simulations with studies such as the Phase 2 Study and the Clarity AD Phase 3 Study. The continued benefits of the treatment-e.g., decreasing amyloid plaque formation with cognitive loss mechanism and focusing on protofibrils to fend off neuronal damage and slow progression of the disease medicalized for optimal treatment with LEQEMBI.

Clinical Efficacy and Impact

Results from the Clarity AD core study showed that compared to placebo, LEQEMBI had significantly reduced cognitive decline, a difference of -0.95 in comparison with a natural historical cohort. The latter showed a slower cognitive decline in LEQEMBI-treated patients, delaying functional and social impairments. The drug has been approved in the U.S., Japan, China, South Korea, and the UK. In January 2025, Eisai applied a subcutaneous autoinjector version of LEQEMBI to serve its purpose for maintenance weekly dosing. The PDUFA action date is August 31, 2025. Continued use of the drug involves the study and optimization of its formulation that might broaden its usage in related maladies, thereby winnowing its chosen role as an Alzheimer's disease therapy.

Conclusion

Protofibrils are the most toxic form of amyloid-beta; they are central to Alzheimer's disease pathogenesis, contributing to damage of neurons, plaque formation, and cognitive impairments. The drug LEQEMBI, doing away with protofibrils, attacks multiple pathways of the disease process. The approval by the FDA of LEQEMBI's IV maintenance dosage represents major strides in Alzheimer's disease health care, enabling long-term benefits and ease of treatment. Despite the product name, LEQEMBI, with its dual-action innovative construct and preferential evidence, is ready to herald with hope millions of patients, and with that their families, worldwide in the early treatment of Alzheimer's. Whilst Eisai and Biogen further their partnerships with expanded treatment modalities that will make LEQEMBI more accessible and transformative for the Alzheimer's population in their treatment, the biggest continued effort is this landmark achievement of science and innovation in addressing one of today's most important conditions.