FDA Approves LEQEMBI IV Maintenance Dosing for Early Alzheimer’s Disease

Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: LEQEMBI) intravenous (IV) maintenance dosing. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S. After 18 months of once every two weeks initiation phase, a transition to the maintenance dosing regimen of 10 mg/kg once every four weeks may be considered or the regimen of 10 mg/kg once every two weeks may be continued.

The sBLA is based on modeling of observed data from the Phase 2 study (Study 201) and its long-term extension (LTE) as well as the Clarity AD study (Study 301) and its LTE study. Modeling simulations predict that transitioning to once every four weeks maintenance dosing after 18 months of once every two weeks treatment will maintain clinical and biomarker benefits of therapy. AD is a progressive, relentless disease caused by a continuous underlying neurotoxic process that begins before and continues after plaque removal. Only LEQEMBI works to fight AD in two ways: continuously clearing protofibrils and rapidly clearing plaque. This is important because with continuous administration, LEQEMBI clears highly toxic protofibrils* which can continue to cause neuronal injury even after the amyloid-beta (Aβ) plaque has been cleared from the brain.