FDA

FDA approves new Kisunla dosing regimen to reduce ARIA-E risk

July 11, 2025

On July 9, 2025, FDA approved an updated label for Kisunla (donanemab-azbt), introducing a new titration-based dosing regimen for adults with early symptomatic Alzheimer’s disease. The change is based on findings from the TRAILBLAZER-ALZ 6 study (NCT05738486), which showed that the modified regimen significantly reduced the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E)—a known risk of amyloid-targeting therapies. Specifically, ARIA-E rates dropped by 41% at 24 weeks and 35% at 52 weeks compared with the original dosing schedule, without compromising efficacy in amyloid plaque or P-tau217 reduction. The new regimen involves a more gradual titration, shifting one vial from the first to the third dose, while maintaining the same cumulative dose by week 24.

The new recommended dosing schedule consists of 3 initial IV infusions given q4wks as follows:

• Infusion 1: 350 mg
• Infusion 2: 700 mg
• Infusion 3: 1050 mg
• Infusion 4 and beyond: 1400 mg IV q4wks

The original dosing schedule called for 700 mg for each of the initial 3 infusions.

Source:

FDA approves updated label for Lilly’s Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer’s disease. [News release]. 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-updated-label-lillys-kisunla-donanemab-azbt-new

Kisunla (donaemab-azbt) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761248s004lbl.pdf Revised July 2025. Accessed July 10, 2025.