Neurological

Eisai begins rolling BLA filing of lecanemab for early-stage Alzheimer’s disease

Eisai has initiated ongoing filing with the Food and Drug Administration for its biologic filing for lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody, for the treatment of early Alzheimer’s disease.

The application is supported by data from a randomized, double-blind phase 2b study (ClinicalTrials.gov Identifier: NCT01767311) in which lecanemab was tested in 856 patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed amyloid disease. Pathology was examined. At 18 months, treatment with lecanemab at the highest doses (10 mg / kg biweekly) reduced brain amyloid by 0.306 SUVr units from a baseline mean of 1.37; over 80% of patients became amyloid negative by visual reading.

The results also showed that a decrease in amyloid levels in the brain correlated with an improvement in cognitive decline, based on the Alzheimer’s Composite Score, Clinical Dementia Rating-Sum-of-Boxes, and Alzheimer’s Disease Assessment Scale-Cognitive Subscale. The incidence of amyloid-related imaging abnormalities – edema / effusion – was 9.9% at the biweekly dose of 10 mg / kg.

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After completion of the proof-of-concept study, 180 patients were examined in the open-label phase 2b extension study. All patients received 10 mg / kg lecanemab biweekly. The results confirmed that lecanemab reduced amyloid PET-SUr, with a significant reduction already occurring after 3 months; Over 80% of the patients achieved an amyloid-negative status by visual reading after just 12 months. The incidence of amyloid-related imaging abnormalities – edema / effusion – was consistent at about 10% at a biweekly dose of 10 mg / kg.

“Based on the efficacy and safety results of the Phase 2b study and the preliminary results of the open label extension study, I am optimistic that lecanemab may have a treatment option for patients with early-stage Alzheimer’s to alleviate the otherwise inevitable decline they face said Jeffrey Cummings, MD, ScD, Lecanemab manuscript author and director at the Chambers-Grundy Center for Transformative Neuroscience, University of Nevada Las Vegas.

Lecanemab is currently being investigated in the Phase 3 Clarity AD study (ClinicalTrials.gov Identifier: NCT03887455) in 1,795 patients with early-stage Alzheimer’s disease; the study was recruited in March 2021. It is also being evaluated in the Phase 3 study AHEAD 3-45 (ClinicalTrials.gov Identifier: NCT04468659) in people with preclinical Alzheimer’s disease who are clinically normal patients with intermediate or elevated amyloid levels in the brain.

reference

Eisai is initiating ongoing US FDA regulatory filing for lecanemab for the treatment of early Alzheimer’s disease under the accelerated regulatory path. Press release. BioArctic. Accessed September 28, 2021. https://www.eisai.com/news/2021/news202177.html.

This article originally appeared on MPR

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