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Date: May 22, 2025
Overview
In a significant development for Alzheimer’s treatment, the Australian Therapeutic Goods Administration (TGA) has granted approval to Eli Lilly’s Kisunla (donanemab), marking the first Alzheimer’s therapy in 25 years in Australia that targets the underlying cause of the disease. Kisunla is designed for adults with early symptomatic Alzheimer’s disease, specifically those who are Apolipoprotein E-ε4 heterozygotes or non-carriers.
Mechanism of Action
Kisunla is a monoclonal antibody that targets amyloid beta plaques in the brain, a hallmark of Alzheimer’s disease. By binding to these plaques, Kisunla facilitates their removal, thereby slowing cognitive and functional decline in patients with early-stage Alzheimer’s.
Clinical Trial Insights
The approval is based on data from the TRAILBLAZER-ALZ 2 Phase 3 study, which demonstrated that Kisunla slowed cognitive and functional decline by up to 35% compared to placebo over 18 months. Additionally, the risk of disease progression was reduced by 39% during the same period.
Administration and Eligibility
Kisunla is administered via intravenous infusion every four weeks. Treatment is intended for individuals with mild cognitive impairment or mild dementia due to Alzheimer’s disease, confirmed by amyloid presence through PET scans or spinal fluid tests.
Side Effects and Considerations
Common side effects include amyloid-related imaging abnormalities (ARIA), which can manifest as brain swelling or bleeding. In clinical trials, ARIA occurred in 36.8% of patients receiving Kisunla, compared to 14.9% in the placebo group. Other side effects may include headache and allergic reactions.
Cost and Accessibility
Without government subsidy, each Kisunla infusion costs approximately $4,700. Eli Lilly has submitted an application for inclusion in the Pharmaceutical Benefits Scheme (PBS) to improve affordability for Australian patients.
Impact on Alzheimer’s Care in Australia
With around 600,000 Australians living with Alzheimer’s disease, and approximately 450,000 in the early stages, Kisunla’s approval offers a new treatment avenue. Experts emphasize the importance of early diagnosis and intervention to maximize the drug’s benefits.
Conclusion
The approval of Kisunla represents a significant advancement in Alzheimer’s treatment in Australia, offering hope to patients and families affected by the disease. Continued research and support are essential to further improve outcomes and accessibility.
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