Eli Lilly’s Kisunla Receives TGA Approval for Early Alzheimer’s Treatment in Australia
Thursday, May 22, 2025
Eli Lilly and Company has received marketing authorisation from the Australian Therapeutic Goods Administration (TGA) for Kisunla (donanemab), a treatment for adults with early symptomatic Alzheimer’s disease.
Kisunla’s Australian approval is also supported by data from the TRAILBLAZER-ALZ 6 study, which assessed a modified dosing schedule aimed at reducing the risk of side effects while maintaining efficacy. These side effects include amyloid-related imaging abnormalities (ARIA), which can occasionally lead to serious, though rare, complications. The product information includes a warning for healthcare professionals to carefully evaluate treatment decisions, particularly in cases where stroke-like symptoms are observed.
The treatment is given every four weeks by infusion and carries the risk of potential side effects, including ARIA and infusion-related reactions.
The approval covers individuals with mild cognitive impairment or mild dementia who are Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Kisunla is administered as an intravenous infusion every four weeks and is the first amyloid-targeting therapy for Alzheimer’s to be registered in Australia.
It is also the only therapy in its class with evidence supporting the option to stop treatment once amyloid plaques have been cleared from the brain.
Kisunla, administered via intravenous infusion every four weeks, is the first registered amyloid-targeting therapy for Alzheimer’s disease in Australia. It is also the only treatment in its class backed by data supporting the option to stop therapy once amyloid plaques have been sufficiently removed.
Amyloid plaques are clumps of protein that form in the brain and are associated with the progression of Alzheimer’s disease. Kisunla works by removing these plaques, which can help slow down cognitive and functional decline in patients during the early stages of the disease.
Around 600,000 Australians are currently living with Alzheimer’s disease, with approximately 450,000 in the early stages and potentially eligible for treatment. The disease is the third leading cause of death in the country.
Donanemab has now been approved in 13 countries, including the United States, Japan, China, the United Kingdom, UAE, Qatar, Kuwait, Bahrain, Singapore, Taiwan, Brazil, Mexico, and Australia.
Source: lilly.com
