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Leqembi Iqlik® for initiation treatment launched in the US

BIOA
  • BioArctic partner Eisai announced that lecanemab-irmb subcutaneous injection (US brand name: Leqembi Iqlik®) is now available in the US for initiating therapy in early Alzheimer's disease.
  • Leqembi Iqlik is the first anti-amyloid treatment approved for at-home initiation & maintenance dosing using an autoinjector instead of intravenous infusions.
  • The approved initiation regimen is 500 mg once weekly, delivered as two 250 mg injections administered in approximately 15 seconds each.
  • Home administration reduces the need for clinic visits & IV infusions, potentially lowering healthcare resource utilization while still requiring MRI monitoring for ARIA.
  • Leqembi is a monoclonal antibody developed via a strategic alliance between BioArctic & Eisai, approved in 53 countries with subcutaneous formulations under review or approved in multiple regions including the US, UK, China, & Japan.
  • BioArctic holds commercialization rights for the Nordic region & receives sales milestone payments & global royalties, while Eisai manages global regulatory interactions & commercialization.
  • Eisai's Phase 3 AHEAD 3-45 study for preclinical Alzheimer's disease is ongoing with full recruitment completed in October 2024.
  • The Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease is ongoing, utilizing lecanemab as the backbone anti-amyloid therapy.