Donanemab, sold under the brand name Kisunla, has been registered by the TGA for adults with early symptomatic Alzheimer’s disease who have a specific genetic profile and the confirmed presence of amyloid plaque in the brain.
The drug is administered intravenously every four weeks, for up to 18 months, and the private prescription price is approximately $4700 for each infusion.
The drug works by inducing antibodies designed to attach to and remove amyloid plaques from the brain.
A global clinic study from the drug’s manufacturer, Eli Lilly, showed donanemab demonstrates comparable and remarkable efficacy in slowing cognitive decline and reducing the accumulation of plaques in individuals with early symptomatic Alzheimer’s disease.
The trial involved 1,700 people (including 16 Australians), aged between 60-85, who all showed symptoms of early-stage AD.
After 12 months, 47% of the group taking donanemab had no evidence of amyloid plaques, compared to 29% in the placebo group. The results also show the drug is able to slow AD progression by 35% in patients in the earliest stages of the disease.
The Australian Dementia Network (ADNeT), a network of leading dementia experts led by the University of Melbourne, welcomed the milestone findings.
Shortly after the results were presented in 2023, ADNeT Screening and Trials Co-Lead Professor Colin Masters told ABC Radio: “When it rolls out in real-world practice we’ll see the full extent of it. At this point, it is a game changer and we’re all very excited about it.”
Eli Lilly says donanemab is the first new treatment for early Alzheimer’s in Australia in 25 years. It said the Pharmaceutical Benefits Advisory Committee is set to review an application to include Kisunla on the Pharmaceutical Benefits Scheme.
Dementia Australia CEO Professor Tanya Buchanan said this drug was an exciting new development and another step forward in the treatment of Alzheimer’s disease.
“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,” Professor Buchanan said.
“It is important to note that donanemab does come with possible side effects that needs to be carefully communicated to patients so they can make an informed choice, and the treatment needs to be monitored by health professionals.”
Eli Lilly said side effects from Kisunla can include amyloid-related imaging abnormalities (ARIA), and infusion-related reactions.
The manufacturer noted ARIA can be fatal. ARIA is most commonly seen as a temporary swelling in an area or areas of the brain that usually goes away over time.
Professor Buchanan noted the need to raise awareness and understanding of dementia so that people with concerns about their cognition are seeking support as early as possible.
“We also need to ensure people understand that donanemab is not a cure and is only suitable for people in the early stages of Alzheimer’s disease with a defined genetic profile – which is why it is so important for people to receive a timely diagnosis,” she said.
If this story has prompted any questions or concerns, please call the National Dementia Helpline 1800 100 500 (24 hours, 7 days a week) or visit dementia.org.au.
