Eisai - Biogen Seek Accelerated Approval For Their Second Alzheimer's Drug

  • Eisai Co Ltd ESALY has completed the rolling submission of the FDA marketing application under the accelerated approval for lecanemab (BAN2401) for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD.
  • Eisai is collaborating with Biogen Inc BIIB for drug development.
  • Eisai has requested a Priority Review, while the lecanemab Phase 3 Clarity AD trial conducted with 1,795 patients will report out in the Fall of 2022. 
  • Also Read: Biogen Fails To Convince Benefits Of Alzheimer's Drug To European Regulator.
  • The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. 
  • Dependent upon the Clarity AD clinical trial results, Eisai may submit for full approval of lecanemab to the FDA during FY22.
  • The submission for lecanemab is based on a clinical, biomarker, and safety data from the proof-of-concept Phase 2b study in 856 patients.
  • At 18 months of treatment, 10 mg/kg biweekly lecanemab reduced brain amyloid by a mean of 0.306 SUVr units (from a baseline mean of 1.37), and over 80% of subjects became amyloid negative by visual read. 
  • The overall rate of amyloid-related imaging abnormalities-edema/effusion, an adverse event associated with anti-amyloid beta antibodies therapies, was 9.9% (16/161) for lecanemab patients compared with 0.8% (2/245) for placebo patients. 
  • Price Action: BIIB shares closed 3.14% lower at $187.54 on Monday.
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