Medicine for early symptomatic Alzheimer

Australians in the early stages of Alzheimer's disease can now be treated with a new medicine that works to remove the build-up of a protein in the brain that can lead to memory loss and impaired thinking.

The Therapeutic Goods Administration (TGA) has registered Kisunla (donanemab), from
Eli Lilly, for the treatment of adults with early symptomatic Alzheimer's disease who have a specific genetic profile* and the confirmed presence of amyloid plaque in the brain.

Kisunla marks the first new treatment for early Alzheimer's disease in 25 years and the first treatment registered in Australia that works to address the underlying cause of the neurodegenerative disease.

Administered via a monthly infusion, Kisunla is a disease modifying therapy that works by clearing amyloid plaques from the brain. The excessive build-up of amyloid plaques in the brain can disrupt the brain's neurons and prevent messages from traveling normally. This can lead to memory and thinking issues associated with Alzheimer's disease, such as remembering new information, important dates and appointments; planning and organising events; making meals; using household appliances; managing finances; and being left alone safely.

"The registration of donanemab is very exciting. As clinicians, we've been waiting a very long time to be able to offer patients a treatment of this nature," said Professor Michael Woodward, Head of Dementia Research and Senior Clinician, Memory Clinic at Austin Health in Melbourne.

"Donanemab is for people in the early stages of Alzheimer's disease with a defined genetic profile, where symptoms like memory lapses and mood changes are present alongside the build-up of amyloid plaques in the brain," he said.

"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."

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. Alzheimer's disease is the third leading cause of death in Australia.

Alzheimer's disease not only limits the ability of people to live and function independently; it also impacts the mental and physical health of carers, with approximately 1.6 million Australians involved in looking after someone living with the memory-robbing illness.

Lilly Australia and New Zealand General Manager Tori Brown said the registration of Kisunla in Australia is "a pivotal moment that will redefine how Alzheimer's disease is managed when symptoms first present".

"The registration of Kisunla in Australia is enormously meaningful for people with early symptomatic Alzheimer's disease who urgently require effective treatment options," she said.

"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."

Ms Brown said the registration of Kisunla "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".

"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."

A reimbursement application to include Kisunla on the Pharmaceutical Benefits Scheme (PBS) will be reviewed by the Pharmaceutical Benefits Advisory Committee (PBAC) in July. The PBAC welcomes input from patients and families impacted by Alzheimer's disease, as well as advocacy groups, clinicians and medical societies.

Until Kisunla is included on the PBS, doctors will be able to prescribe the medicine on private prescription. Lilly is working closely with specialist centres to build confidence and capabilities to translate clinical trial experience with Kisunla into medical practice.

About Kisunla^® (donanemab 350 mg/20 mL)

*Kisunla is an anti-amyloid therapy indicated for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease and Mild Alzheimer's dementia (Early Symptomatic Alzheimer's disease) that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Beta amyloid evidence consistent with Alzheimer's disease (AD) should be confirmed by a specialist in the treatment of Alzheimer's disease using a PET (Positron Emission Tomography) scan or CSF (cerebrospinal fluid) test.

Kisunla is administered via infusion every four weeks. Infusions typically take about 30 minutes to administer and are given through a needle inserted into the arm.

In patients treated with Kisunla, brain swelling and bleeding is more common in people who carry two copies of ApoE ε4, a common gene variant that elevates the risk of developing Alzheimer's disease. Patients must therefore be tested to determine their ApoE ε4 status before starting the therapy. Doctors use magnetic resonance imaging (MRI) scans to monitor for brain bleeding and swelling before and during treatment.

Kisunla is contraindicated in people with hypersensitivity to donanemab or to any of the excipients listed in the Product Information; baseline MRI findings of prior intracerebral haemorrhage greater than 1 cm, more than 2 microhaemorrhages, superficial siderosis or vasogenic oedema (ARIA-E), which are suggestive of cerebral amyloid angiopathy (CAA); severe white matter disease; and any finding that could prevent a satisfactory MRI evaluation for safety monitoring.

Kisunla can cause amyloid-related imaging abnormalities (ARIA), which is a potential side effect with amyloid plaque-targeting therapies that does not usually cause symptoms. It can be detected via MRI scans and, when it does occur, may present as temporary swelling in an area or areas of the brain, which usually resolves over time, or as small spots of bleeding in or on the surface of the brain. Infrequently, larger areas of bleeding in the brain may occur. ARIA can be serious and life-threatening events can occur. Kisunla can also cause certain types of allergic reactions, some of which may be serious and life-threatening, that typically occur during infusion or within 30 minutes post-infusion. Headache, falls and infusion related reactions are other commonly reported side effects.

NB. Kisunla is not available through the Pharmaceutical Benefits Scheme.

About Alzheimer's disease

Alzheimer's disease is the most common form of dementia, accounting for around two-thirds of cases in Australia. It is a physical brain condition that causes a gradual decline in a person's memory, thinking and behaviour.

Alzheimer's disease is caused by a build-up of abnormal proteins in the brain, which disrupts the brain's neurons and prevents messages from traveling normally.

While Alzheimer's disease is not a normal part of ageing, its incidence increases with age, with one-in-30 Australians aged 70 to 74 years, one-in-eight aged 80 to 84 years and one-in-three aged 90 to 94 years estimated to have Alzheimer's disease.

Alzheimer's disease is the third leading cause of death in Australia. The incidence and economic impact of dementia due to Alzheimer's disease and mild cognitive impairment with Alzheimer's disease pathology (~600,000 people impacted at a cost of $8.1 billion in 2024) are expected to double in Australia by 2050.

For support, please contact the National Dementia Helpline on 1800 100 500. 

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