LEQEMBI Pen Approved in Japan for Early Alzheimer's Treatment, Offering Subcutaneous Administration
Eisai Co., Ltd. and Biogen Inc. have announced that the "LEQEMBI Pen," a subcutaneous (SC) formulation of the anti-amyloid beta (Aβ) protofibril antibody LEQEMBI (lecanemab), has received approval in Japan. This approval introduces a new route of administration for the treatment of early Alzheimer's disease. The LEQEMBI Pen is an autoinjector designed for once-weekly administration, either by a care partner or through patient self-administration, delivering two pens totaling 500 mg. This new option complements the existing intravenous (IV) administration, which is given every two weeks in a hospital setting. The approval is based on integrated data from the Phase 3 Clarity AD study and subsequent long-term extension studies, demonstrating comparable efficacy and a generally similar safety profile to the IV formulation, with a lower incidence of systemic injection/infusion-related reactions.
