Eisai Co., Ltd. and Biogen...announced today that 'LEQEMBI Pen', the subcutaneous (SC) formulation of the anti-amyloid beta (Aβ) protofibril antibody 'LEQEMBI' (brand name, generic name: lecanemab) has been approved in Japan as a new route of administration (GlobeNewswire) - Sep 16, 2026 - "LEQEMBI Pen is an autoinjector formulation that enables administration by a care partner or patient self-administration, with two pens (totaling 500 mg) administered once weekly....This approval is based on the integrated results of data and associated modeling and simulation from the 18-month core study of the Phase 3 Clarity AD study of LEQEMBI in patients with mild cognitive impairment (MCI) due to AD or mild AD dementia (collectively referred to as early AD), as well as multiple SC administration sub-studies in its subsequent long-term extension study (LTE)."
Japan approval • Alzheimer's Disease
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