PR Newswire·Sep 16, 2026, 2:18 AM ET

Leqembi® Pen subcutaneous formulation approved in Japan

BioArctic partner Eisai announced the approval of the subcutaneous autoinjector formulation of Leqembi (Leqembi Pen) in Japan for treating early Alzheimer's disease.
The approval allows patients or care partners to self-administer 500 mg doses once weekly at home, complementing the existing twice-monthly intravenous hospital-based treatment.
Each injection takes approximately 15 seconds, potentially reducing treatment time & the burden of clinic visits compared to IV infusions.
Japan is the third country globally to approve this subcutaneous formulation, with similar efficacy to the IV version supported by Phase 3 Clarity AD study data.
Safety monitoring for amyloid-related imaging abnormalities (ARIA) via brain MRI remains required before initiation & at specified intervals, similar to IV administration.
Systemic injection-related reactions were observed less frequently with subcutaneous administration (1.4%) compared to IV administration.
BioArctic holds commercialization rights for lecanemab in the Nordic region under a long-term collaboration agreement with Eisai.
Leqembi is currently approved in 53 countries, with ongoing regulatory reviews in six other regions.