The U.S. Food and Drug Administration has accepted Eisai's supplemental Biologics License Application or sBLA for Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of Leqembi to a traditional approval for the treatment of Alzheimer's Disease, Eisai Co., Ltd. (ESALY.PK,ESALF.PK) and Biogen Inc. (BIIB) said in a statement on Sunday.
The Leqembi application has been granted priority review, with a prescription drug user fee Act (PDUFA) action date of July 6, 2023.
Leqembi is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils) and insoluble forms of amyloid beta (Aß), approved under the Accelerated Approval Pathway for the treatment of Alzheimer's Disease (AD) on January 6, 2023. On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
Treatment with Leqembi should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aß pathology. Leqembi was approved under accelerated approval in the U.S. and was launched in the U.S. on January 18, 2023.
Alzheimer's disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. While the specific causes of Alzheimer's are not fully known, it is characterized by changes in the brain—including amyloid beta plaques and neurofibrillary, or tau, tangles—that result in loss of neurons and their connection.
Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
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