Lecanemab for Potential Treatment of Early Alzheimer’s Disease Fully Submitted to FDA

A rolling submission to the Food and Drug Administration (FDA) for approval lecanemab (BAN2401; Eisai, Tokyo, Japan) for treatment of mild cognitive impairment associated with Alzheimer disease (AD) or mild AD has been completed. 

Submission for approval via the accelerated pathway is based on clinical, biomarker, and safety data from the proof-of-concept phase 2b (Study 201 Core) in 856 people with early AD with confirmed presence of amyloid pathology, biomarker; safety data from the Study 201 open-label extension study (180 subjects); and blinded safety data from the confirmatory Clarity AD phase 3 study (NCT03887455; n=1,795). 

In Study 201, after 18 months of treatment with 10mg/kg biweekly lecanemab, participants had a mean reduction of 0.306 SUVr units (from a baseline mean of 1.37) in amyloid beta (Aβ), and over 80% of participants were amyloid negative on visual reading of amyloid neuroimaging.

The extent of Aβ reduction correlated with slower clinical decline on the Alzheimer's Disease Composite Score (ADCOMS), Clinical Dementia Rating-Sum-of-Boxes (CDR-SB), and Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-cog) tests in those treated with lecanemab. 

In these trials, the overall rate of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with antiAβ antibody therapies, was 9.9% (16/161) of those treated with lecanemab 10mg/kg biweekly compared with 0.8% (2/245) of those treated with placebo. 

"We would like to thank the people living with early AD and the health care professionals who participated in the lecanemab 201 study for their cooperation, allowing completion of this (application) to the FDA. AD is a progressive and devastating disease with few treatment options," said Haruo Naito, chief executive officer at Eisai. "Our comprehensive medicine creation approach along the AD continuum reflects Eisai's long-term commitment to providing innovative treatments to the people living with AD, their families and health care professionals who urgently need new treatment options."