Eisai-Biogen Seek Complete FDA Approval For Its Second Alzheimer's Treatment

  • The FDA has accepted Eisai Co Ltd ESALY and Biogen Inc's BIIB supplemental Biologics License Application (sBLA) for Leqembi (lecanemab-irmb) 100 mg/mL injection, supporting the conversion of the accelerated approval of Leqembi to a traditional approval. 
  • The Leqembi application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. 
  • The FDA plans to hold an Advisory Committee to discuss this application but has not publicly announced the meeting date.
  • Also Read: Biogen's Alzheimer's Antibody Might Have A Third Death Associated With.
  • Leqembi is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils) and insoluble forms of amyloid beta (Aβ).
  • The FDA approved the treatment under the Accelerated Approval Pathway for Alzheimer's Disease (AD). 
  • Treatment with Leqembi should only be initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology. 
  • Eisai leads Leqembi development and regulatory submissions globally, with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
  • Price Action: BIIB shares are down 0.43% at $269.11 on the last check Monday.
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