Neuropharmacology of Lecanemab-irmb: A new drug granted in the treatment of Alzheimer's disease

Abstract

United state food and drug administration approved on 6 January 2023, Lecanemab-irmb via the accelerated approval pathway for the treatment of Alzheimer’s disease. Researchers evaluated Lecanemab-irmb’s efficacy in a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimer’s disease. Treatment was initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed the presence of amyloid beta pathology. Patients receiving the treatment had significant dose and time-dependent reduction of amyloid beta plaque, with patients receiving the approved dose of lecanemab, 10 milligram/kilogram every two weeks, having a statistically significant reduction in brain amyloid plaque from baseline to Week 79 compared to the placebo arm, which had no reduction of amyloid beta plaque. These results support the accelerated approval of Lecanemab-irmb, which is based on the observed reduction of amyloid beta plaque, a marker of Alzheimer’s disease. The amyloid beta plaque was quantified using positron emission tomography (PET) imaging to estimate the brain levels of amyloid beta plaque in a composite of brain regions expected to be widely affected by Alzheimer’s disease pathology compared to a brain region expected to be spared of such pathology.