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Leqembi Iqlik® for initiation treatment launched in the US

  • BioArctic AB partner Eisai announced that lecanemab-irmb subcutaneous injection (Leqembi Iqlik®) is now available in the US for initiating & maintaining therapy for early Alzheimer's disease.
  • Leqembi Iqlik is the first anti-amyloid treatment approved for at-home administration using an autoinjector, eliminating the need for initial intravenous infusions.
  • The US-approved initiation regimen consists of 500 mg once weekly, delivered as two 250 mg injections administered in approximately 15 seconds each.
  • At-home dosing offers patients & carers greater convenience & flexibility while potentially reducing healthcare resource utilization associated with IV administration.
  • MRI monitoring for ARIA remains required before treatment initiation & at specified intervals, consistent with intravenous treatment protocols.
  • Leqembi is approved in 53 countries, with subcutaneous formulations approved in the US, UK, China, & Japan, & applications pending in 12 other regions.
  • Regulatory milestones include priority review designation in China in February 2026 & inclusion in China's Commercial Insurance Innovative Drug List in December 2025.
  • Eisai leads global clinical development & commercialization, while BioArctic holds commercialization rights in the Nordic region & receives sales milestone payments & royalties.
  • BioArctic's Phase 3 AHEAD 3-45 study for preclinical Alzheimer's disease is ongoing after full recruitment in October 2024, & the Tau NexGen study for Dominantly Inherited Alzheimer's disease is also active.
  • BioArctic AB is a Swedish biopharma company listed on Nasdaq Stockholm that utilizes proprietary BrainTransporter™ technology for its neurodegenerative disease portfolio.