Eisai Submits Supplemental Biologics License Application To FDA For Traditional Approval Of LEQEMBI For The Treatment Of Alzheimer's Disease
Submission for traditional approval follows FDA accelerated approval of LEQEMBI on the same day, and is based on data from the confirmatory Phase 3 Clarity AD clinical trial
TOKYO and CAMBRIDGE, Mass., Jan. 6, 2023 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: , Cambridge, Massachusetts, CEO: Christopher A. Viehbacher ", , Biogen", , ))))) announced Eisai has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) supporting the conversion of the Accelerated Approval of LEQEMBI™ (lecanemab-irmb) 100 mg/mL injection for intravenous use to a traditional approval. This sBLA is subject to validation of whether the FDA accepts the application for review. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ("protofibrils")* and insoluble forms of amyloid beta (Aβ), approved under Accelerated Approval Pathway by the FDA on January 6, 2023, for the treatment of Alzheimer's Disease (AD). Treatment with LEQEMBI should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology.