The Australian Therapeutic Goods Administration (TGA) has approved Eli Lilly and Company’s (Lilly) Kisunla (donanemab) for use in treating early symptomatic Alzheimer’s disease.
Kisunla is an intravenous therapy administered every four weeks. It is aimed at adults experiencing mild cognitive impairment or mild dementia due to Alzheimer’s, specifically those who are Apolipoprotein E ε4 heterozygotes or non-carriers.
This approval marks the first amyloid-targeting therapy for Alzheimer’s in Australia, with Kisunla being the only treatment backed by evidence to support discontinuation once amyloid plaques are eliminated.
Amyloid plaques are protein accumulations that can lead to cognitive decline. Kisunla targets and aids in the reduction of these plaques, aiming to slow cognitive and functional deterioration in individuals with early-stage Alzheimer’s.
Currently, around 600,000 Australians are estimated to live with Alzheimer’s, nearly 450,000 of whom may be eligible for treatment with Kisunla. Alzheimer’s stands as the third leading cause of death in Australia.
The approval is underpinned by data from the TRAILBLAZER-ALZ 2 Phase 3 study. The trial showed Kisunla reduced cognitive and functional decline by up to 35% over 18 months compared to a placebo and decreased the risk of disease progression by 39% within the same period.
However, amyloid-related imaging abnormalities (ARIA), such as oedema and haemorrhage, are potential side effects. These occurrences are often asymptomatic but can be serious. Consequently, a boxed warning advises careful consideration of clot-dissolving treatments.
A modified titration schedule approved in Australia, based on TRAILBLAZER-ALZ 6 data, has been shown to lower the incidence of ARIA-E at 24 weeks while maintaining Kisunla’s efficacy. This revised schedule is also under review for approval in other countries.
Lilly executive vice president Ilya Yuffa said: “It is exciting to see Kisunla’s marketing authorisation in Australia, marking it as the 13th regulatory authorisation.
“In our TRAILBLAZER-ALZ 2 Phase 3 study, results showed that Kisunla significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease, which allowed them more time to do things that mattered most to them like remember information, make meals, manage finances, and maintain independence.
“As our data showed, the earlier patients are identified, diagnosed, and treated with Kisunla, the greater their response to treatment.”
Donanemab is now approved in multiple regions including the US, Japan, China, and several others beyond Australia.
