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FDA Approves Monthly Maintenance Dosing for LEQEMBI® in Alzheimer’s Treatment

NextEdge Admin

29 Jan 2025

2 min 32 sec

Eisai Co., Ltd.,Biogen Inc.,LEQEMBI®,Alzheimer’s disease

Eisai Co., Ltd. and Biogen Inc. announced that the U.S. FDA has approved the Supplemental Biologics License Application (sBLA) for once-every-four-weeks maintenance dosing of LEQEMBI® (lecanemab-irmb) IV for Alzheimer’s disease (AD). LEQEMBI is indicated for early AD, including mild cognitive impairment (MCI) and mild dementia stages. After 18 months of biweekly treatment (10 mg/kg), patients may transition to monthly maintenance dosing or continue the biweekly regimen.

The approval is based on data modeling from the Phase 2 (Study 201) and Clarity AD (Study 301) trials, which predict that monthly maintenance dosing will sustain clinical and biomarker benefits. LEQEMBI is the only treatment that both rapidly clears amyloid-beta (Aβ) plaques and continuously removes toxic protofibrils, which can still cause neuronal damage after plaque removal.

Data from an off-treatment period between studies showed that stopping treatment led to reaccumulation of Aβ and biomarkers, as well as a return to the placebo rate of clinical decline. Ongoing treatment may slow disease progression, helping patients maintain cognitive function longer. In the 18-month Clarity AD study, LEQEMBI reduced cognitive decline by -0.45 on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale. Over three years, the reduction reached -0.95 compared to a natural history cohort, demonstrating a meaningful benefit.

LEQEMBI is approved in multiple countries, including the U.S., Japan, China, and the U.K. In January 2025, the FDA accepted an application for a subcutaneous autoinjector for weekly maintenance dosing, with a decision expected by August 31, 2025. Eisai leads global development and regulatory submissions, with both companies co-commercializing the product.