Australia has approved a new drug to treat early-stage Alzheimer’s disease, with Kisunla (donanemab) now available for prescription by specialists following registration by the Therapeutic Goods Administration (TGA).
Developed by Eli Lilly, Kisunla is already in use across the United States, United Kingdom, China and Japan. The drug targets amyloid plaques in the brain, which are associated with Alzheimer’s pathology.
The following video outlines the benefits of Kisnula after it was approved by the Therapeutics Goods Administration (TGA) in the US.
Clinical trials in Australia were led by Professor Michael Woodward, head of Dementia Research and Senior Clinician at Austin Health’s Memory Clinic, and Honorary Medical Adviser at Dementia Australia. “My experience is this drug is very effective at removing amyloid in the majority of people by 18 months,” he told the Herald Sun. “You basically turn the brain from an Alzheimer’s brain into a non-Alzheimer’s brain.”
First new Alzheimer’s therapy in years
Kisunla is administered through monthly infusions and is the first new Alzheimer’s therapy approved in Australia in 25 years. It is intended for individuals with mild cognitive impairment or mild dementia, and only for those confirmed to have amyloid protein in the brain through PET scans or spinal fluid analysis.
Health Minister Mark Butler said the registration was “a landmark welcome development”. “It is 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.”
The drug is not yet listed on the Pharmaceutical Benefits Scheme (PBS), and an application is under review for July. Without PBS funding, the cost of treatment is A$4,700 per infusion across an 18-month course.
Critical milestone for patients
Kisunla’s availability marks a critical step for patients like 80-year-old Michael Pratt, who participated in a clinical trial after experiencing mild memory decline. “A bit of my time was not terribly valuable when you consider that for a lot of people in the future, it might be a very good thing for them,” he said.
Professor Woodward emphasised that while the treatment slows progression, it is not a cure and is not suitable for all patients. Those with specific health conditions or using certain medications may be excluded due to risks of cerebral bleeding and swelling.
Lilly Australia and New Zealand General Manager Tori Brown described the registration as “a pivotal moment” that should prompt reform in diagnosis and access to treatment. “This must include practical guidelines and new pathways for the early detection and diagnosis of Alzheimer’s disease,” she said.
The approval has personal significance for Australians like Joel Fulton, a former book publisher diagnosed with younger-onset Alzheimer’s at 62. His wife Diane now acts as his full-time carer. “We need [the drug] now, before Joel’s symptoms get much worse,” she told The Herald Sun, hoping the treatment might offer them more time together.