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Eisai/Biogen’s Lecanemab Effective Across Endpoints, But Will Safety Limit Use?

CTAD Presentation Is First Detailed Data

 
• By Mandy Jackson

Alzheimer’s patients treated with the amyloid protofibril-clearing antibody had slower disease progression compared to placebo, with differences increasing over time. Safety concerns, however, are growing. 

Alzheimer's disease on MRI
Amyloid-related imaging abnormalities were among the most common adverse events • Source: Shutterstock

Detailed results from the Phase III Clarity AD clinical trial of Eisai Co., Ltd./Biogen, Inc.’s lecanemab in patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild AD showed slower cognitive and functional declines over time, but concerns have emerged about deaths from brain hemorrhages, particularly in people on anticoagulants.

The Clarity AD results, presented on 29 November at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in San Francisco and simultaneously published in the New England Journal of Medicine, also showed low rates of amyloid-related imaging abnormalities (ARIA) relative to other trials of anti-amyloid therapies, according to the investigators

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