Eisai Posts New Lecanemab Data From Mid-Stage Alzheimer's Trial

  • Eisai Co Ltd ESALY and Biogen Inc BIIB announced results of sensitivity analyses evaluating the consistency of lecanemab efficacy results across multiple statistical models in patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease (AD) and mild AD.
  • The data were presented at the 2021 Clinical Trials on Alzheimer's Disease (CTAD) conference.
  • In September, Eisai initiated a rolling submission of a Biologics License Application (BLA) for lecanemab for early AD to the FDA under the accelerated approval pathway.
  • The study achieved the goal of identifying the smallest dose that achieved over 90% of maximum treatment effect (10 mg/kg biweekly), i.e., the ED90 dose. 
  • At 12 months, the ED90 dose had a 64% probability of being super-superior to placebo by a 25% reduction and 98% probability superior to placebo. 
  • The consistent treatment effect was observed at 18 months for Alzheimer's Disease score (29% to 37%), dementia score (26.5% to 35%), and Cognitive scale (47% to 56%), with separation from placebo observed by six months for the top dose (10mg/kg biweekly) across all analyses.
  • Price Action: BIIB shares are down 0.13% at $266.57, and ESALY shares are down 0.01% at $71.68.
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Posted In: BiotechNewsHealth CareGeneralAlzheimer's diseaseBriefs
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