Lilly’s Kisunla (Donanemab) Gains Marketing Authorization in Australia for Early Alzheimer’s Treatment
Eli Lilly and Company has announced that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab), a novel treatment for early symptomatic Alzheimer’s disease. The approval marks a significant milestone, as Kisunla becomes the first amyloid-targeting therapy for Alzheimer’s disease registered in Australia. It is also the only therapy of its kind with clinical evidence supporting cessation of treatment once amyloid plaques are cleared from the brain.
Kisunla is administered via intravenous infusion every four weeks and is specifically indicated for adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease, who are either Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. This targeted approach reflects the precision medicine trend in Alzheimer’s treatment, ensuring that the therapy reaches patients most likely to benefit from it.
A New Era in Alzheimer’s Treatment in Australia
Alzheimer’s disease poses a serious public health challenge in Australia. An estimated 600,000 Australians are currently living with the condition, with approximately 450,000 believed to be in the early symptomatic stages. These individuals may be eligible for assessment and treatment with Kisunla. Alarmingly, Alzheimer’s is now the third leading cause of death in Australia, highlighting the urgent need for more effective interventions.
Kisunla offers a promising option by addressing one of the key hallmarks of the disease: amyloid plaques. Amyloid is a naturally occurring protein in the body, but in Alzheimer’s disease, it can accumulate in the brain and form plaques that interfere with neuron-to-neuron communication. These plaques are closely associated with the cognitive and functional decline observed in Alzheimer’s patients.
Donanemab works by targeting and removing these amyloid plaques, thereby potentially slowing disease progression. Importantly, Lilly’s data suggest that once amyloid plaques are sufficiently cleared, treatment with Kisunla may be stopped, making it a distinctive option among current therapies, which typically require continuous administration.
Backed by Robust Clinical Evidence
The Australian approval is supported by extensive data from Lilly’s TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 clinical trials.
The Phase 3 TRAILBLAZER-ALZ 2 study was pivotal. It showed that Kisunla significantly slowed the rate of cognitive and functional decline by up to 35% compared to placebo over 18 months. Additionally, it reduced the risk of progression to the next clinical stage of the disease by 39% during the same period. These improvements translated into tangible benefits for patients, such as retaining the ability to remember important information, manage daily activities like cooking and handling finances, and maintain personal independence longer.
“The marketing authorization of Kisunla in Australia is a major step forward,” said Ilya Yuffa, Executive Vice President and President of Lilly International. “This marks the 13th regulatory authorization for Kisunla globally. The data from TRAILBLAZER-ALZ 2 clearly show that earlier diagnosis and intervention are crucial to maximizing the potential benefits of treatment. By initiating therapy in the earliest stages, we can help preserve function and quality of life for a longer time.”
Addressing Safety Concerns Through New Dosing Strategy
Like other amyloid-targeting therapies, donanemab is associated with amyloid-related imaging abnormalities (ARIA), which include ARIA-E (edema or effusion) and ARIA-H (hemorrhage or hemosiderosis). These events are typically asymptomatic, but in rare cases, they can be serious or even life-threatening.
To address this, the product information approved by the TGA includes a boxed warning noting that ARIA-E can present with symptoms mimicking ischemic stroke, and physicians should carefully consider the use of therapies aimed at dissolving blood clots in affected patients.
To mitigate the risk of ARIA, Lilly developed and tested a modified titration schedule in its TRAILBLAZER-ALZ 6 study. The results showed a significantly lower incidence of ARIA-E at 24 weeks compared to the original dosing regimen, while still preserving the drug’s ability to reduce amyloid plaque and levels of the Alzheimer’s-related biomarker plasma P-tau217. This modified titration schedule is what has been approved in Australia and is also under regulatory review in other markets.
Expanding Global Access
With Australia now added to the list, Kisunla is approved in 13 countries. These include the United States, Japan, China, United Kingdom, United Arab Emirates, Qatar, Kuwait, Bahrain, Singapore, Taiwan, Brazil, Mexico, and now Australia. The international spread of approvals signals growing confidence among regulators in Kisunla’s risk-benefit profile and underscores Lilly’s commitment to making the therapy globally accessible.
Kisunla’s unique “stop-treatment” model distinguishes it from other Alzheimer’s therapies currently on the market. Most available treatments require long-term or even lifelong administration, which can be burdensome for patients, caregivers, and healthcare systems. In contrast, the possibility of halting treatment once a specific biological target is achieved — in this case, the elimination of amyloid plaques — reflects a potential paradigm shift in the way Alzheimer’s is treated.
A Glimpse Into the Future of Alzheimer’s Care
The approval of Kisunla in Australia adds momentum to the evolving landscape of Alzheimer’s disease therapy, where disease-modifying treatments are finally beginning to take shape after decades of failed trials and limited options. The focus is gradually shifting from symptom management to addressing the underlying pathology of the disease.
Moreover, the success of Kisunla highlights the value of biomarker-driven clinical development. The use of amyloid PET scans and other diagnostic tools to confirm the presence of amyloid plaques before treatment not only ensures that the right patients are treated but also enables precise monitoring of therapeutic effects.
As governments and healthcare providers grapple with the societal and economic burden of Alzheimer’s, the need for early diagnosis and access to therapies like Kisunla becomes even more urgent. Beyond just offering a new treatment, Kisunla represents a new standard of care in how Alzheimer’s disease may be tackled going forward.
Lilly’s Kisunla has earned a place in history as Australia’s first approved amyloid-targeting therapy for early Alzheimer’s, backed by rigorous clinical evidence and a forward-thinking approach to patient care. Its availability offers new hope to the hundreds of thousands of Australians in the early stages of the disease — hope for slower decline, for longer independence, and for more meaningful time with loved ones.
With regulatory momentum continuing to build across the globe, Kisunla’s journey reflects both a scientific triumph and a beacon of progress in the battle against one of the most devastating neurodegenerative diseases of our time.
