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Leqembi® Pen subcutaneous formulation approved in Japan

BIOA
  • BioArctic AB partner Eisai announced the approval in Japan on September 16, 2026, of the Leqembi Pen, a subcutaneous autoinjector formulation for early Alzheimer's disease.
  • The new formulation allows patients or care partners to self-administer 500 mg injections once weekly at home, replacing the existing twice-monthly hospital-based intravenous (IV) infusion.
  • Each subcutaneous injection takes approximately 15 seconds, reducing treatment time & the burden of clinic visits compared to IV administration.
  • This approval lowers barriers to treatment initiation & continuation while potentially reducing healthcare resources needed for nurse monitoring & infusion capacity.
  • Japan is the third country globally to approve the subcutaneous formulation, with monitoring for amyloid-related imaging abnormalities (ARIA) requiring brain MRI scans before & during treatment.
  • Clinical data from the Phase 3 Clarity AD study & long-term extension sub-studies showed the weekly 500 mg subcutaneous dose provides efficacy comparable to the IV formulation with a similar safety profile.
  • Systemic injection-related reactions occurred less frequently with subcutaneous administration (1.4%) compared to IV administration.
  • Self-administration will be available after listing in the injectable drug list, typically within 60 days of approval, requiring initial physician supervision & patient training.
  • BioArctic holds commercial rights for the Nordic region & is entitled to sales milestone payments & royalties on global sales of lecanemab.
  • Leqembi is currently approved in 53 countries, with additional regulatory reviews ongoing in six other regions.