for early Alzheimer's disease (subcutaneous maintenance dosing)
sBLA· Standard Review
FDA approved Leqembi Iqlik (lecanemab) subcutaneous starting-dose regimen for early Alzheimer's disease on July 13, 2026 — 6 weeks ahead of the extended August 24 PDUFA target. The subcutaneous starting-dose formulation enables at-home administration, replacing the biweekly IV infusion currently required for treatment initiation.
About
Alzheimer's disease is a progressive brain disorder that begins with memory loss and eventually impairs language, mood, and basic bodily functions. Leqembi Iqlik is an antibody treatment, delivered via an at-home injection, that targets and clears a harmful protein called amyloid beta from the brain. By removing this protein, the drug may slow the cognitive and functional decline associated with early Alzheimer's.
