FDA Clears Safer Dosing Schedule for Lilly’s Alzheimer’s Drug Kisunla

The U.S. Food and Drug Administration approved an updated prescribing label for Eli Lilly’s Alzheimer’s drug Kisunla, introducing a revised titration schedule for adults with early symptomatic disease. The new regimen, which applies to patients with mild cognitive impairment or mild dementia and confirmed amyloid pathology, redistributes one vial from the first to the third dose while keeping the once-monthly intravenous dosing and total drug exposure unchanged through 24 weeks. Regulators based the decision on data from the Phase 3b TRAILBLAZER-ALZ 6 trial, where the modified schedule cut the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) to 14% at 24 weeks and 16% at 52 weeks. Those figures represent relative reductions of 41% and 35%, respectively, compared with the original dosing plan, without compromising Kisunla’s ability to clear amyloid plaque or lower plasma P-tau217 levels. ARIA-E, often asymptomatic but potentially serious, is a known class effect of amyloid-targeting therapies. Lilly said the label change will help physicians manage safety while maintaining the drug’s disease-modifying benefits for people in the earliest stages of Alzheimer’s.