BRIEF—FDA accepts Eisai’s sBLA filing for Leqembi

The US Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing.

A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025.

Partnered with Biogen, Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).

As part of the proposed monthly IV maintenance regimen, the patients who have completed the biweekly IV initiation phase, exact period under discussion with the FDA, would receive a monthly IV dose that maintains effective drug concentration to sustain the clearance of highly toxic protofibrils which can continue to cause neuronal injury.

The sBLA is based on modeling of observed data from the Phase II study (Study 201) and its open-label extension (OLE) as well as the Clarity AD study (Study 301) and its OLE study.