FDA Approves LEQEMBI (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer’s Disease

Eisai Co., Ltd. and Biogen Inc. announced that under the Accelerated Approval Pathway the U.S. Food and Drug Administration (FDA) has approved lecanemab-irmb (Brand Name in the U.S.: LEQEMBI™) 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (“protofibril”)* and insoluble forms of amyloid beta (Aβ) for the treatment of Alzheimer’s disease (AD). The approval is based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD. Using the recently published data from the large global confirmatory Phase 3 clinical trial, Clarity AD, Eisai will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.