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FDA Approves LEQEMBI™ (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease
Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with LEQEMBI™ Treatment with LEQEMBI
About this update from Biogen Inc.
[{"type":"text","content":"Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with LEQEMBI™\nTreatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials\nTOKYO 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 today 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.\n\n \n \n \n \n \n \n\n \nINDICATIONLEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with LEQEMBI. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.\nDOSAGE AND ADMINISTRATION (Patient Selection, Dosing Instructions, Monitoring and Dosing Interruption for ARIA)The recommended dosage of LEQEMBI is 10 mg/kg administered intravenously once every two weeks to eligible patients with confirmed presence of Aβ pathology prior to initiating treatment. Enhanced clinical vi...