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Leqembi® Pen subcutaneous treatment launched in Japan

  • Eisai launched Leqembi Pen, the subcutaneous formulation of lecanemab, in Japan on November 13, 2026, marking the second country after the US to introduce this treatment for early Alzheimer's disease.
  • The product received approval in Japan on September 16, 2026, & was subsequently added to the National Health Insurance (NHI) Drug Price List.
  • Leqembi Pen is the first & only anti-amyloid treatment in Japan enabling at-home administration via an autoinjector.
  • The approved regimen consists of a 500 mg dose once weekly, delivered through two pens, offering an alternative to the bi-weekly intravenous (IV) administration at medical facilities.
  • At-home use allows for self-administration by patients or care partners under physician guidance after training, potentially reducing clinic visits & healthcare resource usage.
  • MRI monitoring for amyloid-related imaging abnormalities (ARIA) remains mandatory prior to treatment initiation & at specified intervals, consistent with IV protocols.
  • BioArctic AB collaborates with Eisai on lecanemab development & commercialization, holding rights to commercialize the drug in the Nordic region & receiving milestone payments & royalties on global sales.
  • Leqembi is currently approved in 53 countries, with subcutaneous initiation treatment approved in China & Japan in September 2026, & regulatory reviews ongoing in four additional countries.
Company
BioArctic
Keywords
BioArctic