First Alzheimer’s treatment in over two decades signals major shift in patient care

Eli Lilly has broken a 25-year stalemate in Alzheimer’s disease treatment with the TGA registration of its amyloid-targeting monoclonal antibody, Kisunla (donanemab).

“This registration of [Kisunla] donanemab is very exciting. As clinicians, we’ve been waiting a very long time to offer patients a treatment of this nature,” remarked Professor Michael Woodward, Head of Dementia Research at Austin Health in Melbourne.

It’s estimated that 600,000 Australians are currently living with Alzheimer’s disease, with approximately 450,000 of these in the early stages of the disease who could be assessed to determine eligibility for treatment with Kisunla. The therapy is administered via infusion every four weeks, typically taking around 30 minutes.

“There is an important window of opportunity when it is possible to detect, diagnose and treat Alzheimer’s disease with the goal that patients can maintain their independence for longer. The availability of donanemab is a major development at a time when more and more Australians and their families are being impacted by this insidious disease,” Professor Woodward emphasised.

“With dementia the second leading cause of death of Australians, and the leading cause of death of Australian women, we welcome any steps taken towards improving the lives of people living with dementia, their families and carers,” said Dementia Australia CEO Professor Tanya Buchanan.

Dementia Australia advocate Peter Duclos, who was recently diagnosed with younger onset Alzheimer’s disease, said the announcement was really positive. 

“This announcement provides hope to many people like me who are living with dementia – it provides much excitement now as well as for a future that prolongs time to enjoy with my grandchildren,” Duclos said. 

Tori Brown, General Manager of Lilly ANZ, stated “The registration of Kisunla in Australia is enormously meaningful for people with early symptomatic Alzheimer’s disease who urgently require effective treatment options.

“Lilly has been at the forefront of Alzheimer’s disease research for more than 35 years. It’s incredibly rewarding to know that these tireless efforts have led to this moment in time.”

However, regulatory approval is only the first step. With Kisunla scheduled for consideration by the Pharmaceutical Benefits Advisory Committee (PBAC) in July 2025, the healthcare system faces pressing questions about whether it is equipped to deliver on the promise of this new treatment.

A national clinician survey involving neurologists, geriatricians, and psychiatrists across 30 clinics revealed several gaps in readiness – from infrastructure to workforce capacity and clinical guidelines.

Many clinics lack basic IV infusion facilities and clear care models to guide treatment and monitoring. Clinicians are also concerned about safety risks, particularly amyloid-related imaging abnormalities (ARIA), with no structured systems in place for ongoing oversight.

Brown stressed that Kisunla’s registration “must act as a catalyst for change, ensuring Australia’s healthcare system is equipped to support the early detection, diagnosis and treatment of Alzheimer’s disease”.

She added, “This must include practical guidelines and new pathways for the early detection and diagnosis of Alzheimer’s disease, alongside timely Government reimbursement of therapies to support patient access and affordability.”

Professor Buchanan echoed this sentiment, saying “As this and other treatments become available in Australia, we need to ensure that our health systems are ready and to make sure that access to treatment is equitable and available to everyone.”

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