Research & Development
Eisai submits supplemental Biologics License Application to FDA for monthly lecanemab-irmb IV maintenance dosing
1 April 2024 -

Japan-based pharmaceutical company Eisai, a partner of Swedish biopharma company BioArctic AB (STO:BIOA-B), announced on Monday that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for monthly lecanemab-irmb (US brand name: Leqembi) intravenous (IV) maintenance dosing.

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 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 even after the amyloid-beta (A-beta) plaque has been cleared from the brain. The sBLA is based on modelling of observed data from the Phase 2b study (Study 201) and its open-label extension (OLE), as well as Clarity AD study (Study 301) and its OLE study.