FDA Approves New Dosing Schedule for Lilly's Alzheimer's Drug Kisunla

The U.S. Food and Drug Administration (FDA) has approved a new, more gradual titration dosing schedule for Eli Lilly's Kisunla (donanemab-azbt), a once-monthly amyloid-targeting therapy for early symptomatic Alzheimer's disease. This updated regimen, supported by the TRAILBLAZER-ALZ 6 study, significantly reduces the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E), a potentially serious side effect involving brain swelling, by 35-41% compared to the original dosing schedule. The new dosing shifts the initial doses to start with one vial and gradually increases to the full dose by month four, maintaining the same overall amount of drug by week 24 without compromising its efficacy in amyloid plaque removal or slowing cognitive decline. Kisunla's improved safety profile with fewer and less severe ARIA-E events enhances its benefit-risk balance and is expected to aid healthcare professionals in treatment decisions. Despite its efficacy, adoption of Kisunla and similar drugs remains slow due to the need for extra diagnostic tests and monitoring for side effects. The label update reflects Lilly's commitment to patient safety and advancing Alzheimer's treatment options.