Eisai Co., Ltd., in collaboration with Biogen Inc., has formally announced the submission of a rolling supplemental biologics license application (sBLA) to the United States Food and Drug Administration (FDA) for IQLIK. This product represents a subcutaneous auto-injector formulation of lecanemab, designed to be administered as a weekly starting dose. Prior to this, the FDA had already granted Fast Track status to the drug. Lecanemab is specifically developed as a therapeutic option for individuals in the early stages of Alzheimer's disease.
The foundation for this application lies in the assessment outcomes of a multi-dose range for subcutaneous delivery, derived from a sub-study within the Phase 3 Clarity AD open-label extension trial. The launch of this new formulation is anticipated to offer patients a more accessible and user-friendly treatment alternative, aligning with the evolving needs and preferences of the healthcare community and patients alike.