FDA Approves New Kisunla Dosing Regimen to Lower Alzheimer's Risk

The FDA has approved a new dosing regimen for Kisunla to lower the risk of ARIA-E, a serious side effect of brain swelling, in patients with early symptomatic Alzheimer's disease. The new regimen involves a gradual titration of the medication, with less given on the first dose and more on the third, while maintaining the total amount delivered. This update aims to mitigate the risk of ARIA-E and aid healthcare professionals in evaluating appropriate treatment options for patients.

The U.S. Food and Drug Administration (FDA) has approved an updated label for Lilly's Kisunla (donanemab-azbt), a once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD). The new recommended dosing schedule aims to significantly lower the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E), a serious side effect of brain swelling, without compromising the drug's efficacy.

The updated dosing regimen involves a more gradual titration, with a single vial shifted from the first dose to the third dose, delivering the same total amount of Kisunla by week 24. This modification resulted in a 41% lower incidence of ARIA-E at 24 weeks and a 35% lower incidence at 52 weeks compared to the original dosing schedule [1].

The TRAILBLAZER-ALZ 6 study, which supported this label update, enrolled 843 participants and demonstrated that the modified titration schedule significantly lowered ARIA-E rates while maintaining similar levels of amyloid plaque removal and P-tau217 reduction [1]. The study also showed no new adverse reactions, although higher rates of hypersensitivity and infusion-related reactions were observed.

"By significantly reducing the risk of ARIA-E, we can offer patients and care teams greater confidence in the safety of Kisunla while preserving its ability to reduce amyloid," said Elly Lee, MD, Chief Medical Officer and Principal Investigator at the Irvine Center for Clinical Research [1].

The FDA approved Kisunla in July 2024 based on the TRAILBLAZER-ALZ 2 Phase 3 clinical trial data, which demonstrated that Kisunla significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer's disease [1].

The updated dosing regimen for Kisunla is a meaningful advancement for patients and their care teams, as it addresses a significant safety concern while maintaining the drug's efficacy. Healthcare professionals can now evaluate appropriate treatment options for their patients with greater confidence in the safety of Kisunla.

References:
[1] https://investor.lilly.com/news-releases/news-release-details/fda-approves-updated-label-lillys-kisunla-donanemab-azbt-new