Clearing Amyloid Provides Alzheimer’s Benefit, But With Risks That Need Careful Management

The Phase III Clarity AD clinical trial of Eisai Co., Ltd./Biogen, Inc.’s lecanemab was warmly received at the recent Clinical Trials on Alzheimer’s Disease (CTAD) meeting as the first pivotal trial to unequivocally show that removing amyloid from the brains of Alzheimer’s patients can slow disease progression. But as much as the study’s results invigorated the field, the data also indicated some patients may opt out of treatment because of safety risks.

Eisai does not expect amyloid-related imaging abnormalities (ARIA) – either with edema (ARIA-E) or hemorrhage (ARIA-H) – and emerging cases of patients on anticoagulant therapy who died from brain macrohemorrhages to impact lecanemab’s ability to win US Food and Drug Administration approval