The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s (Lilly) revised label for Kisunla (donanemab-azbt) by introducing an updated dosing schedule for the treatment of early symptomatic Alzheimer’s disease.
This revision involves a new titration dosing strategy aimed at decreasing the risk of side effects while maintaining efficacy in amyloid plaque reduction.
The label adjustment results from findings of the TRAILBLAZER-ALZ 6 study, which showed that the new dosing regimen reduced the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E) significantly.
Under the modified titration schedule, there was a 41% reduction in ARIA-E cases at 24 weeks and a 35% decrease at 52 weeks compared to the original dosing plan.
Lilly Alzheimer’s disease global and US medical affairs vice president Brandy Matthews said: “We are confident that this label update for Kisunla will significantly aid healthcare professionals in evaluating appropriate treatment options for their patients.
“This update underscores our unwavering commitment to patient safety and the advancement of Alzheimer’s disease treatment by potentially mitigating the risk of ARIA-E.”
Kisunla is designed for patients experiencing mild cognitive impairment or those in the early stages of Alzheimer’s dementia, confirmed to have amyloid pathology.
The updated recommendation shifts one vial from the first to the third dose, delivering an equivalent quantity of medication by week 24. Despite this alteration, comparable levels of amyloid plaque and P-tau217 reduction were observed.
During TRAILBLAZER-ALZ 6, patients on the revised dosing had a lower occurrence of side effects related to amyloid plaque treatment without impacting the agent’s efficacy. Specifically, there was a similar degree of amyloid plaque removal among participants in both dosing groups after 24 weeks.
Originally, Kisunla was authorised by the FDA in July 2024. This was following evidence from its Phase 3 clinical trials which indicated that Kisunla could slow cognitive degeneration by up to 35% in individuals with less advanced pathology over an 18-month duration.
The therapy also proved effective in reducing progression to more severe stages of Alzheimer’s disease by 37%.
Kisunla is administered as an intravenous injection provided in a single-dose vial format.
