The autoinjector delivers a weekly maintenance dose of 360 mg lecanemab for individuals who have completed biweekly treatment initiation by IV infusion.
The AdComm plans to review data from the TRAILBLAZER-ALZ 2 phase 3 clinical trial that served as the foundation for Eli Lilly's original BLA submission to the FDA.
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.