The sBLA for once-monthly maintenance IV dosing of lecanemab is complete but a rolling application for a weekly subQ option has been set back, said Eisai.
The surprise request for review of the phase 3 TRAILBLAZER-ALZ-2 clinical trial findings will delay the original PDUFA timing beyond first quarter 2024.
The accuracy of the test in detecting Aβ and tau pathology underscores its potential to become an accessible and cost effective tool for Alzheimer diagnosis.
At the Clinical Trials on Alzheimer's Disease Meeting, October 24-28, the biotech company will update research on lecanemab, aducanumab, and an early-stage disease treatment.