Eisai and Biogen Announce Eisai's Initiation of Rolling Submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for LEQEMBI® (Lecanemab) Subcutaneous Auto-Injector (SC-AI) IQLIK as a Weekly Starting Dose, Following FDA's Grant of Fast Track Designation. Lecanemab is Used to Treat Patients with Early Alzheimer's Disease (AD) Who Have Mild Cognitive Impairment or Mild Dementia.
The submission of this supplemental Biologics License Application (sBLA) is based on the evaluation of subcutaneous (SC) administration across multiple dose ranges in a sub-study of the Phase III Clarity AD open-label extension study (OLE), following an 18-month core study conducted in patients with early Alzheimer's disease. If the U.S. Food and Drug Administration (FDA) approves the lecanemab IQLIK 500mg subcutaneous dosing regimen (two 250mg injections), this auto-injector formulation can be used for once-weekly initial dosing, serving as an alternative to once-every-two-weeks intravenous (IV) administration. This will allow patients and caregivers to administer lecanemab at home from the start of treatment through the maintenance phase, offering a choice between intravenous and subcutaneous administration. Currently, each injection with the lecanemab IQLIK auto-injector takes approximately 15 seconds. The subcutaneous formulation is expected to reduce healthcare resource utilization associated with IV maintenance dosing, such as infusion preparation and nurse supervision, while streamlining the overall treatment process for Alzheimer’s disease.
Lecanemab has been approved for marketing in 48 countries and is currently under review in 10 countries.
Eisai Co., Ltd. leads the global development and registration application of lecanemab, while the product is co-commercialized and promoted by Eisai Co., Ltd. and Biogen Inc. Among them, Eisai Co., Ltd. has the final decision-making authority.
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