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 the most common form of dementia, gradually robbing people of memory, language, and independence until bodily functions fail and the disease becomes fatal. Leqembi Iqlik is a lab-made antibody given as an under-the-skin injection that binds to harmful clumps of amyloid protein in the brain and helps clear them. Because those clumps are thought to drive the nerve damage behind Alzheimer's, this at-home treatment may slow the disease's progression while sparing families repeated clinic infusions.
