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New clinical data on the Leqembi® subcutaneous autoinjector presented at AAIC® 2026 support similar efficacy and safety to IV formulation in early Alzheimer's disease

BIOA
  • BioArctic AB partner Eisai presented new data at the 2026 Alzheimer's Association International Conference (AAIC) in London demonstrating that the Leqembi (lecanemab) subcutaneous autoinjector (SC-AI) offers efficacy & safety comparable to intravenous (IV) administration for early Alzheimer's disease.
  • The findings support a fully subcutaneous treatment pathway from initiation through maintenance, offering greater convenience & flexibility for patients & care partners.
  • Once-weekly 500 mg SC-AI achieved bioequivalence to the approved IV initiation regimen (10 mg/kg every two weeks) with an exposure ratio of 104% (90% CI: 99.1%–109%).
  • Drug exposure remained consistent across body weight quartiles, supporting the use of a fixed-dose regimen & indicating that efficacy is driven by exposure rather than the route of administration.
  • Amyloid clearance measured by PET, clinical efficacy measured by CDR-SB, & ARIA-E incidence were consistent across patient populations & not meaningfully affected by body weight.
  • Patients may switch between IV & SC administration as needed, with flexibility to administer a missed dose the following day or up to six days later.
  • The overall safety profile of SC-AI aligned with the IV formulation, including a predicted ARIA-E incidence similar to the IV regimen & low anti-drug antibody rates of 1.4% with no neutralizing antibodies.
  • Real-world data from two US treatment centers showed slower cognitive decline over 36 months & high satisfaction rates (75%–97%) regarding convenience & willingness to recommend the treatment.
  • The US FDA granted Priority Review in January 2026 for Eisai's supplemental Biologics License Application (sBLA) regarding a subcutaneous starting dose, with an extended PDUFA date of August 24, 2026.
  • BioArctic holds commercialization rights for lecanemab in the Nordic region & is entitled to sales milestones & royalties on global sales through its long-term collaboration with Eisai.