Eisai and Biogen Announce FDA Acceptance of LEQEMBI® Application for Early Alzheimer’s Disease Treatment
Tuesday, January 14, 2025
Eisai and Biogen have announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for LEQEMBI® (lecanemab-irmb) subcutaneous autoinjector (SC-AI) for maintenance dosing.
Alzheimer’s disease is a progressive neurological condition driven by a toxic process that persists before and after amyloid plaque deposition in the brain.
LEQEMBI has been shown to work in two ways: clearing toxic protofibrils and rapidly reducing plaque levels. Long-term data presented at the Alzheimer’s Association International Conference in 2024 suggest that early and continuous use of LEQEMBI could prolong therapeutic benefits, even after plaque has been cleared.
This treatment is intended for individuals with early-stage Alzheimer’s disease (AD), including those with mild cognitive impairment (MCI) or mild dementia.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of 31 August 2025.
The application is supported by data from the Clarity AD (Study 301) open-label extension and predictive modelling of clinical outcomes.
If approved, LEQEMBI will be the first Alzheimer’s treatment available for weekly subcutaneous administration at home using an autoinjector.
The injection process is expected to take approximately 15 seconds. This new option would follow a biweekly intravenous (IV) initiation phase, after which patients could switch to weekly subcutaneous doses to maintain clinical and biomarker benefits.
The SC-AI method is designed to simplify treatment by reducing the need for hospital visits or nursing care required for IV administration. It is expected to make ongoing maintenance treatment more accessible for patients and their caregivers, streamlining the overall management of Alzheimer’s disease.
LEQEMBI has already been approved in multiple countries, including the United States, Japan, China, South Korea, and the United Kingdom.
It recently received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, recommending approval in the European Union.
Eisai and Biogen continue to co-develop, co-commercialise, and co-promote LEQEMBI globally, with Eisai leading regulatory activities and holding final decision-making authority.
Source: biogen.com
