FDA Approves New Dosing Regimen for Kisunla in Alzheimer Disease

The Food and Drug Administration (FDA) has updated the labeling for Kisunla^™ (donanemab-azbt) to include a new recommended titration dosing schedule for adults with early symptomatic Alzheimer disease (AD). 

Kisunla is a humanized immunoglobulin gamma 1 monoclonal antibody directed against insoluble N-truncated pyroglutamate amyloid beta. The once-monthly therapy was approved in July 2024 for the treatment of AD in patients with mild cognitive impairment or mild dementia stage of disease.

The updated labeling includes a new recommended dosing schedule: donanemab 350mg for the first infusion, 700mg for the second infusion, 1050mg for the third infusion, and 1400mg for every infusion thereafter. Prior to this change, patients had been receiving donanemab 700mg for the first 3 infusions, followed by 1400mg for each subsequent infusion (original dosing regimen).  

The amended titration schedule was approved based on results from the phase 3 TRAILBLAZER-ALZ 6 trial (ClinicalTrials.gov Identifier: NCT05738486). The study evaluated different donanemab dosing regimens in adults aged 60 to 85 years with early symptomatic AD. The primary endpoint was the percentage of participants with any occurrence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at 24 weeks.

Findings showed the incidence of ARIA-E was lower with the newly recommended dosing schedule compared with the original dosing regimen at 24 weeks (14% vs 24%) and at 52 weeks (16% vs 25%). At week 52, ARIA, ARIA-E, and ARIA-H (amyloid-related imaging abnormalities-hemorrhage) were observed in 29%, 16%, and 25% of patients receiving the new regimen, respectively. 

Notably, amyloid plaque and P-tau217 reductions were found to be similar in patients receiving the new and original dosing regimens. The analysis showed amyloid plaque levels were reduced on average by 67% from baseline with the new titration schedule and 69% with the original dosing regimen.

“This updated dosing strategy is a meaningful advancement for patients and their care teams,” said Elly Lee, MD, Chief Medical Officer and Principal Investigator, Irvine Center for Clinical Research. “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.” 

This article originally appeared on MPR