A Supplemental Biologics License Application (sBLA) was filed to the U.S. Food and Drug Administration (FDA) by Eisai for Lecanemab-irmb (U.S. brand name: LEQEMBI®), the approved drug for treating mild cognitive impairment or early Alzheimer’s Disease (AD).
Alzheimer’s Disease (AD) is the most common cause of dementia where aggregates of amyloid beta (Aβ) plaques and neurofibrillary tangles of tau protein accumulate in the brain. The most toxic form of Aβ is protofibril. Continuous removal of protofibrils from the brain is necessary in patients even after clearance of Aβ plaque to prevent neuronal injury. Therefore, patients who have completed the bi-weekly initiation phase of LEQEMBI will benefit from monthly intravenous administration to maintain effective drug concentration for sustainably clearing away highly toxic protofibrils.
Earlier, Eisai submitted a Biologics License Application (BLA) under Fast Track designation for weekly maintenance therapy using subcutaneous (SC) administration. The Fast Track designation will be determined within 60 days from the March 2024 submission.
Rueben Das, PhD
