FDA Approves Updated Dosing for Lilly’s Kisunla to Lower Brain Swelling Risk

The FDA has approved a modified dosing schedule for Eli Lilly's Alzheimer's drug Kisunla (donanemab-azbt) to reduce the risk of brain swelling, a side effect known as amyloid-related imaging abnormalities (ARIA)15.

The new titration regimen starts with a smaller first dose—a single 350 mg vial for the initial monthly infusion—followed by a more gradual increase, compared to the previous schedule15.

This adjustment was validated in the TRAILBLAZER-ALZ 6 study, demonstrating significantly lower rates of ARIA-E (edema/effusion) at 24 and 52 weeks, while still achieving similar amyloid plaque removal and P-tau217 reduction as the original schedule5.

ARIA has been a major safety concern for anti-amyloid Alzheimer's drugs and contributed to prescribing hesitancy as well as regulatory rejections in some regions13.

Kisunla was originally approved in July 2024 for early symptomatic Alzheimer’s disease, targeting toxic amyloid beta plaques in the brain13.

The new FDA-approved dosing is expected to improve safety and make treatment a more viable option for patients with early Alzheimer’s, including those with mild cognitive impairment5.

Sources:

1. https://www.biopharmadive.com/news/kisunla-modified-dosing-fda-approve-lilly-donanemab/752554/

3. https://www.beingpatient.com/fda-approves-dosing-kisunla-safety/

5. https://www.prnewswire.com/news-releases/fda-approves-updated-label-for-lillys-kisunla-donanemab-azbt-with-new-dosing-in-early-symptomatic-alzheimers-disease-302500615.html