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

Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. announced the completion of the rolling submission of the Supplemental Biologics License Application (sBLA) for lecanemab-irmb (LEQEMBI) subcutaneous autoinjector (SC-AI) to the FDA, which is indicated for the treatment of Alzheimer's disease in early stages [1][5]. Group 1: Product Development and Approval - The sBLA is supported by data from Phase 3 studies showing that once-weekly administration of 500 mg SC-AI provides equivalent exposure and similar clinical benefits compared to bi-weekly intravenous administration [2][3]. - If approved, the LEQEMBI IQLIK autoinjector will allow patients to self-administer the treatment at home, potentially reducing healthcare resource utilization associated with IV dosing [3][5]. - LEQEMBI is currently approved in 51 countries and regions and is under regulatory review in 9 countries, with the FDA having previously approved a 360 mg weekly subcutaneous maintenance dose [5][30]. Group 2: Mechanism of Action - LEQEMBI targets both protofibrils and amyloid plaques, which are implicated in the neurotoxic processes of Alzheimer's disease [4][29]. - Protofibrils are considered the most toxic form of amyloid-beta and are believed to contribute significantly to cognitive decline in Alzheimer's patients [6][29]. Group 3: Safety and Efficacy - The safety profile of subcutaneous administration is comparable to intravenous administration, with less than 2% incidence of systemic injection-related reactions [2][3]. - Incidence of amyloid-related imaging abnormalities (ARIA) was observed at 21% for LEQEMBI compared to 9% for placebo, with symptomatic ARIA occurring in 3% of patients [12][31]. - Serious intracerebral hemorrhages (ICH) were reported in 0.7% of patients taking LEQEMBI, compared to 0.1% with placebo [13][31]. Group 4: Collaboration and Market Strategy - Eisai leads the global development and regulatory submissions for lecanemab, while both Eisai and Biogen co-commercialize and promote the product [5][33]. - The collaboration between Eisai and BioArctic has been ongoing since 2005, focusing on the development and commercialization of Alzheimer's disease treatments [34].