- 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.
