FDA Accepts LEQEMBI IQLIKTM (lecanemab-irmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease under Priority Review

The U.S. Food and Drug Administration has accepted for review a supplemental biologics license application from Eisai for lecanemab-irmb. The product, branded LEQEMBI IQLIK, is proposed as a weekly subcutaneous starting dose for the treatment of early Alzheimer's disease. The application was granted priority review. A prescription drug user fee act action date has been set for May 24, 2026. Supporting data came from sub-studies within the phase 3 clarity AD open-label extension. Once-weekly administration of 500 milligrams via subcutaneous autoinjector achieved exposure equivalent to the current bi-weekly intravenous regimen. It also produced similar clinical and biomarker benefits. The safety profile of subcutaneous administration was similar to intravenous use, with less than 2 percent incidence of systemic injection or infusion-related reactions. The formulation could reduce healthcare resources required for intravenous dosing, including infusion preparation and nurse monitoring. Eisai leads lecanemab development and regulatory submissions globally and co-commercializes the treatment with Biogen.