Eisai Initiated Rolling Supplemental Biologics License Application to the U.S. FDA for LEQEMBI® IQLIK™ (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status

Core Insights - Eisai Co., Ltd. and Biogen Inc. have initiated the rolling submission of a Supplemental Biologics License Application (sBLA) for lecanemab-irmb (LEQEMBI) subcutaneous autoinjector (SC-AI) to the U.S. FDA, following the grant of Fast Track Status [1][28] - The sBLA is based on Phase 3 clinical studies and aims to provide an alternative weekly dosing regimen for patients with early Alzheimer's disease (AD) [2][6] - LEQEMBI is currently approved in 48 countries and under regulatory review in 10 countries, indicating a strong global interest in the treatment [3][28] Company Overview - Eisai serves as the lead for lecanemab's development and regulatory submissions globally, with co-commercialization efforts alongside Biogen [4][32] - The collaboration between Eisai and Biogen has been ongoing since 2014, focusing on the joint development and commercialization of Alzheimer's disease treatments [32] - Eisai's corporate concept emphasizes patient-centric approaches and aims to address high unmet medical needs, particularly in neurology [34] Product Details - LEQEMBI is indicated for the treatment of Alzheimer's disease, specifically for patients with Mild Cognitive Impairment (MCI) or mild dementia [6][27] - The new subcutaneous formulation is expected to streamline treatment pathways and reduce healthcare resource utilization compared to intravenous dosing [2][3] - The autoinjector allows for administration at home, enhancing patient convenience and adherence to treatment [2][28] Clinical Insights - LEQEMBI targets both amyloid plaque and protofibrils, which are believed to contribute to cognitive decline in Alzheimer's disease [3][5] - The treatment has shown a favorable safety profile, with specific monitoring guidelines for potential adverse effects such as Amyloid-Related Imaging Abnormalities (ARIA) [11][21] - Clinical trials have reported varying incidences of ARIA, with symptomatic ARIA occurring in 3% of patients treated with LEQEMBI [11][12] Market Potential - The approval of the subcutaneous formulation could position LEQEMBI as a leading treatment option for Alzheimer's disease, particularly in the U.S. market [1][28] - The ongoing Phase 3 clinical studies for preclinical Alzheimer's disease further highlight the potential for expanding the treatment's indications [29][30] - The collaboration with BioArctic has been instrumental in the development of lecanemab, showcasing the importance of strategic partnerships in advancing Alzheimer's therapies [27][33]