Lilly's Kisunla Gets FDA Approval with New Dosing Schedule for Early Alzheimer's Disease Treatment

The FDA has approved a label update for Lilly's Kisunla (donanemab-azbt) with a new dosing schedule for early symptomatic Alzheimer's disease. The updated schedule significantly lowers ARIA-E rates compared to the original dosing schedule, while maintaining amyloid plaque removal and P-tau217 reduction levels. The new dosing regimen involves a gradual titration, resulting in a 41% lower incidence of ARIA-E at 24 weeks and a 35% lower incidence at 52 weeks versus the original dosing schedule.