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LEQEMBI® Pen (Subcutaneous Formulation of LEQEMBI®) Now Available in Japan for Patients with Early Alzheimer’s Disease

BIIB
  • Eisai Co., Ltd. & Biogen Inc. launched the LEQEMBI Pen (lecanemab) subcutaneous formulation in Japan on November 12, 2026.
  • The subcutaneous route was approved in Japan on September 16, 2026, & listed on Japan's National Health Insurance Drug Price List on the launch date.
  • Japan is the second country globally to launch this subcutaneous formulation, following the United States.
  • LEQEMBI Pen is an autoinjector delivering 500 mg total (two pens) once weekly, enabling patient self-administration or care partner administration.
  • Treatment offers a once-weekly subcutaneous option alongside the existing intravenous infusion schedule of every two weeks.
  • The injection time is approximately 15 seconds, potentially reducing administration time & healthcare resource usage compared to IV infusions.
  • Self-administration at home or while traveling may increase treatment flexibility & reduce the burden of clinic visits for patients & caregivers.
  • Initiating treatment requires administration by a physician or under direct physician supervision at a medical facility.
  • Self-administration is permitted only after thorough education, training, & confirmation that the patient or caregiver understands risks & can reliably administer the drug under physician guidance.
  • Brain MRI monitoring for amyloid-related imaging abnormalities (ARIA) remains required prior to initiation & at specified time points post-treatment.
  • LEQEMBI Pen targets both protofibrils & amyloid plaques to slow progression of mild cognitive impairment (MCI) & mild dementia due to Alzheimer's disease.
  • The NHI drug price is set at 27,141 JPY per pen, with packaging containing two 1.25mL pens.
  • Clinical data indicates the subcutaneous formulation provides efficacy comparable to intravenous administration with a similar safety profile & fewer systemic injection/infusion-related reactions.
  • Eisai leads global development & regulatory submissions for lecanemab, with both companies co-commercializing the product under Eisai's final decision-making authority.
  • Lecanemab is currently approved in 53 countries & regions, including Japan, the U.S., China, Canada, Europe, South Korea, Taiwan, & Saudi Arabia.
  • Phase 3 AHEAD 3-45 study for preclinical Alzheimer's disease & the Tau NexGen study for Dominantly Inherited Alzheimer's disease are ongoing.
Company
Biogen Inc.
Keywords
Nasdaq:BIIB, Biogen Inc.