Eli Lilly’s Kisunla Receives Regulatory Approval in Australia for Early Alzheimer’s Treatment
Eli Lilly and Company (NYSE: LLY) announced today that Australia’s Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab), an intravenous infusion therapy administered every four weeks. The drug is approved for treating adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease who are Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.
Kisunla is the first amyloid-targeting therapy approved in Australia for Alzheimer’s disease and the only one shown to justify stopping treatment once amyloid plaques have been sufficiently cleared from the brain.
Amyloid, a naturally occurring protein, can accumulate and form plaques in the brain—a hallmark of Alzheimer’s disease. Kisunla is designed to reduce this buildup and help slow cognitive and functional decline in people with early symptomatic Alzheimer’s.
“The approval of Kisunla in Australia marks the 13th global regulatory authorization for this important therapy,” said Ilya Yuffa, Executive Vice President and President of Lilly International. “Our Phase 3 TRAILBLAZER-ALZ 2 study showed Kisunla significantly slowed the decline in memory and daily functioning, allowing patients to maintain independence and quality of life for longer. The earlier treatment begins, the better the potential outcomes.”
Currently, around 600,000 Australians are living with Alzheimer’s, with approximately 450,000 in the early stages—potential candidates for Kisunla. Alzheimer’s disease is the third leading cause of death in Australia.
Backed by Robust Clinical Evidence
Kisunla’s approval is based on data from the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 clinical trials:
- In TRAILBLAZER-ALZ 2, Kisunla was shown to slow cognitive and functional decline by up to 35% at 18 months compared to placebo.
- It also reduced the risk of disease progression to a more severe clinical stage by 39% during the same period.
Safety and Dosing Considerations
As with other amyloid-targeting therapies, Kisunla can cause amyloid-related imaging abnormalities (ARIA), which may include edema (ARIA-E) or microbleeds (ARIA-H). Although often asymptomatic, these side effects can occasionally lead to serious complications. As a precaution, the Australian prescribing information includes a boxed warning, advising caution in patients requiring treatment for blood clots, due to ARIA-E’s potential to mimic stroke symptoms.
Australia has approved a modified titration schedule based on the TRAILBLAZER-ALZ 6 study. This updated regimen significantly reduced the incidence of ARIA-E at 24 weeks, while maintaining Kisunla’s effectiveness in reducing both amyloid plaques and plasma P-tau217, a biomarker linked to Alzheimer’s.
Global Footprint Expands
With this latest approval, Kisunla (donanemab) is now authorized for use in 13 countries, including the United States, Japan, China, the United Kingdom, UAE, Qatar, Kuwait, Bahrain, Singapore, Taiwan, Brazil, Mexico, and Australia. Regulatory submissions for the updated dosing schedule are under review in additional countries.
About Kisunla
In Australia, Kisunla is an amyloid-targeting treatment for people with mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients who are ApoE ε4 heterozygotes or non-carriers. Kisunla can cause serious side effects, including amyloid-related imaging abnormalities (ARIA), and infusion-related reactions. Donanemab is a prescription medicine administered intravenously every four weeks.
About TRAILBLAZER-ALZ 2 Study
TRAILBLAZER-ALZ 2 (NCT04437511) was a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer’s disease (mild cognitive impairment or mild dementia due to Alzheimer’s disease) with the presence of confirmed Alzheimer’s disease neuropathology. The trial enrolled 1,736 participants, across 8 countries, selected based on cognitive assessments in conjunction with evidence of Alzheimer’s disease pathology. The Phase 3 TRAILBLAZER-ALZ 2 study results were published in the Journal of the American Medical Association
