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Benzinga
Benzinga
Technology
Vandana Singh

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

  • Eisai Co Ltd (OTC: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 (NASDAQ: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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