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FDA approves Leqembi Iqlik® (lecanemab-irmb) subcutaneous injection as a starting dose for early Alzheimer's disease

BIOA
  • The US FDA approved a supplemental Biologics License Application for Leqembi Iqlik (lecanemab-irmb) as a once-weekly subcutaneous starting dose for early Alzheimer's disease.
  • The US launch of Leqembi Iqlik is scheduled for late August 2026.
  • Leqembi Iqlik is administered via autoinjector as two 250 mg injections per week, replacing the need for intravenous infusions from the start of treatment.
  • Patients can now receive Leqembi as subcutaneous injections throughout the entire treatment course, including initiation & maintenance, allowing flexibility to switch between administration methods.
  • Clinical data from the Phase 3 Clarity AD long-term extension showed that once-weekly subcutaneous dosing achieves exposure equivalent to intravenous dosing with similar efficacy & amyloid removal benefits.
  • The safety profile for subcutaneous initiation is comparable to intravenous administration, with no increase in isolated ARIA-H & most injection-related reactions being localized.
  • Subcutaneous initiation aims to reduce clinic visit burdens, reliance on infusion resources, & treatment preparation time while preserving infusion capacity for those who require it.
  • An autoinjector acceptability study indicated that 94% of patients & care partners found the Leqembi Iqlik device easy to use.
  • Leqembi is currently approved in 53 countries & under regulatory review in 6 countries, with recent advancements in Japan, China, & the US regarding subcutaneous formulations.
  • BioArctic AB holds commercialization rights for lecanemab in the Nordic region & receives royalties & milestone payments from global sales through its partnership with Eisai.