US FDA Approves Eisai and Biogen's sBLA for Monthly IV Dose of Lecanemab

Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Supplemental Biologics License Application (sBLA) for lecanemab-irmb, administered intravenously (IV) once every four weeks as a maintenance dose. LEQEMBI is approved for managing Alzheimer's disease (AD) in individuals experiencing mild cognitive impairment (MCI) or mild dementia stage of the illness (together known as early AD) in the United States. Following an 18-month initiation phase where it is administered once every two weeks, a shift to a maintenance dose of 10 mg/kg every four weeks can be considered, or the 10 mg/kg dosing once every two weeks may be maintained.

The sBLA relies on modeling data observed from the Phase 2 clinical study (Study 201) and its long-term extension (LTE), along with the Clarity AD study (Study 301) and its LTE. Modeling simulations suggest that shifting to a maintenance dosing schedule of once every four weeks after 18 months of biweekly treatment will preserve the clinical and biomarker advantages of the therapy.

AD is a progressive and unyielding condition induced by a persistent neurotoxic mechanism that starts before and persists after the removal of plaques.1,2,3 Only LEQEMBI combats AD in two ways: consistently clearing protofibrils and quickly eliminating plaques. This is significant as persistent use of LEQEMBI removes extremely harmful protofibrils* that may keep causing neuronal damage even after the amyloid-beta (Aβ) plaque has been eliminated from the brain.