JUL 13, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Lecanemab Autoinjector (Efficacy)
U.S. Food and Drug Administration
FDA supplemental approval of lecanemab autoinjector formulation; regulatory action record that does not contain clinical trial efficacy or safety data.
Reported
Approval date2026-07-13
Product strength360 mg/1.8 mL (200 mg/mL)