The Australian Dementia Network (ADNeT) is disappointed with the decision by the Therapeutic Goods Administration (TGA) to reject the use of lecanemab in Australia. This decision denies Australians access to a therapy that has been shown to slow cognitive decline and is at odds with its approval in the United States, Japan, China, South Korea, Israel and the United Kingdom.
The TGA based its decision on concerns that the demonstrated efficacy of lecanemab did not outweigh the associated safety risks, particularly the occurrence of amyloid-related imaging abnormalities (ARIA) seen in clinical trials. Lecanemab shows a significant reduction in disease progression. However, the TGA deemed this improvement not substantial enough to justify the safety concerns.
However, Professor Christopher Rowe, Director of ADNeT, believes the benefits of lecanemab outweigh the risks, especially when appropriate measures are in place:
“Alzheimer’s is a devastating disease that progressively robs individuals of their independence and places an enormous burden on families and caregivers. Even a modest delay in cognitive decline means an extension of quality time for patients, enabling them to remain in their homes longer and delay entry into aged care. While safety concerns about ARIA are valid, these risks can be managed with careful patient selection, close monitoring and regular brain imaging, as has been demonstrated in other countries where lecanemab has been approved.”
In countries where lecanemab is available, strict monitoring protocols are implemented to mitigate the risk of ARIA. The risks are higher in persons who carry two APOE-e4 genes, so the UK authorities have excluded these persons from the treatment while the US FDA has advised extra care. Close monitoring with MRI scans is required in the first 6 months of treatment when these problems are most likely to occur. Fatalities in the clinical trial of lecanemab were very rare.
Professor Rowe added that “ADNeT understands the need for thorough safety evaluations, but it is essential to weigh these against the very real and devastating impact of Alzheimer’s disease. We urge the TGA to collaborate with international regulators and the pharmaceutical industry to find a path forward that allows for access to lecanemab while ensuring patient safety”.
Professor Colin Masters from ADNeT and Florey Institute, University of Melbourne said “These disease modifying therapies for Alzheimer’s can delay or even halt the progression of the disease if given early enough. When used at the earliest possible stages of symptomatic Alzheimer’s disease, these therapeutics are showing more than 60% slowing of disease progression. This breakthrough represents the first effective medication for Alzheimer’s disease in our community.”
Professor Michael Breakspear from ADNeT and the University of Newcastle said that the decision was puzzling, given that we now have access to accurate blood-based diagnostic tests and a deeper understanding of the disease than ever before. “This is the first time we have had affordable diagnostics followed by medical treatments for Alzheimer’s disease, the leading cause of death in the Australian community. Those with the financial means may decide to travel for treatment overseas, but most people living with the disease in Australia will be unable to access this treatment even when they understand and accept the relative risks and benefits.”
As leaders in dementia, ADNeT call on the Government for more investment in dementia research, early diagnosis, treatment, prevention and post diagnostic support. Professor Sharon Naismith, lead of the ADNeT memory clinics initiative from the University of Sydney, highlights that regardless of the TGA decision, our State, Territory and Commonwealth governments must invest in our health system preparedness for dementia. “We are lagging behind other countries in many ways. In the Mild Cognitive Impairment and early dementia stages, we could do so much to promote optimal brain health, quality of life and maintain independence, yet we have a massive evidence to practice gap. We need a radical shift in perspective towards more timely diagnosis and support, at all stages of disease.”
Though the TGA decision on lecanemab is disappointing, scientists and the pharmaceutical industry are pushing ahead with many trials of new drugs and new diagnostic tests that will change the future for persons at risk of developing Alzheimer’s disease. “I remain very optimistic that continued scientific progress will deliver new and effective treatments over the next few years for Alzheimer’s disease” stated Professor Rowe. “ADNeT remains committed to supporting the development and introduction of new treatments for Alzheimer’s disease and other causes of dementia.”
Dementia in Australia: A Growing Challenge
According to the Australian Institute of Health and Welfare (AIHW), dementia is the leading cause of disease burden in Australia. It is the leading cause of death for Australian women. As of 2023, an estimated 411,100 Australians are living with dementia, with the majority being over the age of 65. This is equivalent to 84 people with dementia per 1,000 Australians aged 65 and over. This number is expected to rise to over 849,300 by 2058. Dementia is the leading cause of death for Australian women. The condition also places significant pressure on the aged care system, with 52% of residents in permanent aged care living with dementia.
These statistics underscore the urgent need for more effective treatments, research, and early intervention to reduce the personal and societal burden of dementia.
Media enquiries:
Prof. Christopher Rowe MD FRACP FAANMS
Director, Australian Dementia Network, University of Melbourne
Director, Molecular Imaging Research, Austin Health
Senior Researcher, Florey Institute of Neuroscience and Mental Health
Direct Mobile: +61 (0) 419 110 348
Email: Christopher.ROWE@austin.org.au
Prof Colin L Masters MD
The Florey Institute, The University of Melbourne
Direct Mobile: +61 (0) 408 510 747
Email: c.masters@unimelb.edu.au
BIO Professor Christopher Rowe is a neurologist and nuclear medicine physician, working in the Memory Disorders Clinic and the Molecular Imaging Department of Austin Health, and leading research teams at Austin Health, University of Melbourne and the Florey. He is the Director of the Australian Dementia Network (ADNeT) and is the AIBL study of Ageing imaging leader. As well as 405 publications, he has been a Highly Cited Researcher (top 1% world-wide) for Neuroscience and Behaviour since 2016. THE AUSTRALIAN named him Australia’s leading researcher in Neurology in 2019 and Geriatric Medicine from 2020 to 2023. His research focus is PET brain imaging and blood biomarkers for Alzheimer’s disease (AD) to advance understanding of this disease and the translation of recent advancements in diagnostics and therapies for AD into clinical practice.
BIO Colin Masters has focused his career on research in Alzheimer’s disease and other neurodegenerative diseases, including Creutzfeldt-Jakob disease. His work over the last 40 years is widely acknowledged as having had a major influence on Alzheimer’s disease research world-wide, particularly the collaborative studies conducted with Konrad Beyreuther in which they discovered the proteolytic neuronal origin of the Aβ amyloid protein which causes Alzheimer’s disease. This work has led to the continued development of diagnostics and therapeutic strategies. More recently, his focus has been on describing the natural history of Alzheimer’s disease as a necessary preparatory step for therapeutic disease modification. Professor Masters is currently a Professor at the Florey Institute, the University of Melbourne. He is also a consultant at the Royal Melbourne Hospital. His achievements have been recognised by the receipt of many international awards.
ABOUT The Australian Dementia Network (ADNeT) is a partnership of leading dementia researchers from across 21 universities and research institutions in Australia, led by the University of Melbourne. To register interest in volunteering for ADNeT clinical trials visit: https://www.australiandementianetwork.org.au