Latest news with #Donanemab
Hans India
27-05-2025
- Health
- Hans India
Donanemab gets Australian nod for treatment of Alzheimer's disease
This week, Australia's Therapeutic Goods Administration (TGA) approved a drug called donanemab for people in the early stages of Alzheimer's disease. Donanemab has previously been approved in a number of other countries, including the United States. So what is donanemab, and who will be able to access it in Australia? How does donanemab work? There are more than 100 different causes of dementia, but Alzheimer's disease alone accounts for about 70 per cent of these, making it the most common form of dementia. The disease is believed to be caused by the accumulation in the brain of two abnormal proteins, amyloid and tau. The first is thought to be particularly important, and the 'amyloid hypothesis' – which suggests amyloid is the key cause of Alzheimer's disease – has driven research for many years. Donanemab is a 'monoclonal antibody' treatment. Antibodies are proteins the immune system produces that bind to harmful foreign 'invaders' in the body, or targets. A monoclonal antibody has one specific target. In the case of donanemab it's the amyloid protein. Donanemab binds to amyloid protein deposits (plaques) in the brain and allows our bodies to remove them. Donanemab is given monthly, via intravenous infusion. What does the evidence say? Australia's approval of donanemab comes as a result of a clinical trial involving 1,736 people published in 2023. This trial showed that there was a significant slowing of disease progression in a group of patients who had either early Alzheimer's disease, or mild cognitive impairment with signs of Alzheimer's pathology. Before entering the trial, all patients had the presence of amyloid protein detected via PET scanning. Participants were randomised, and half received donanemab, while the other half received a placebo, over 18 months. For those who received the active drug, their Alzheimer's disease progressed 35 per cent more slowly over 18 months compared to those who were given the placebo. Researchers ascertained this using the Integrated Alzheimer's Disease Rating Scale, which measures cognition and function. Those who received donanemab also demonstrated large reductions in the levels of amyloid in the brain (as measured by PET scans). The majority, by the end of the trial, were considered to be below the threshold that would normally indicate the presence of Alzheimer's disease. These results certainly seem to vindicate the amyloid hypothesis, which had been called into question by the results of multiple failed previous studies. They represent a major advance in our understanding of the disease. That said, patients in the study did not improve in terms of cognition or function. They continued to decline, albeit at a significantly slower rate than those who were not treated. The actual clinical significance has been a topic of debate. Some experts have questioned whether the meaningfulness of this result to the patient is worth the potential risks. Is the drug safe? Some 24 per cent of trial participants receiving the drug experienced brain swelling. The rates rose to 40.6 per cent in those possessing two copies of a gene called ApoE4. Although three-quarters of people who developed brain swelling experienced no symptoms from this, there were three deaths in the treatment group during the study related to donanemab, likely a result of brain swelling. These risks require regular monitoring with MRI scans while the drug is being given. Around 26.8 per cent of those who received donanemab also experienced small bleeds into the brain (microhaemorrhages) compared to 12.5 per cent of those taking the placebo. Cost is a barrier: Reports indicate donanemab could cost anywhere between 40,000 and 80,000 Australian dollars. This puts it beyond the reach of many who might benefit from it. Eli Lilly, the manufacturer of donanemab, has made an application for the drug to be listed on the Pharmaceutical Benefits Scheme, with a decision pending perhaps within a couple of months. While this would make the drug substantially more affordable for patients, it will represent a large cost to taxpayers. The cost of the drug is in addition to costs associated with the monitoring required to ensure its safety and efficacy (such as doctor visits, MRIs and PET scans). Who will be able to access it? This drug is only of benefit for people with early Alzheimer's-type dementia, so not everybody with Alzheimer's disease will get access to it. Almost 80 per cent of people who were screened to participate in the trial were found unsuitable to proceed. The terms of the TGA approval specify potential patients will first need to be found to have specific levels of amyloid protein in their brains. This would be ascertained either by PET scanning or by lumbar puncture sampling of spinal fluid. Also, patients with two copies of the ApoE4 gene have been ruled unsuitable to receive the drug. The TGA has judged the risk/benefit profile for this group to be unfavourable. This genetic profile accounts for only 2 per cent of the general population, but 15 per cent of people with Alzheimer's disease. Improving diagnosis and tempering expectations: It is estimated more than 400,000 Australians have dementia. But only 13 per cent of people with dementia currently receive a diagnosis within a year of developing symptoms. Given those with very early disease stand to benefit most from this treatment, we need to expand our dementia diagnostic services significantly. Finally, expectations need to be tempered about what this drug can reasonably achieve. It's important to be mindful this is not a cure. (The writer is associated with Monash University)
The Age
25-05-2025
- Health
- The Age
Brain scan to detect Alzheimer's before symptoms appear is world first
It has already been designated by the US Food and Drug Administration for use in the United States as a 'breakthrough' device. The neuroscientist behind the advances said it meant medical professionals were able to see changes in the brain far earlier, at a level normally only be possible via a post-mortem examination. Over the past year, two major treatments for Alzheimer's disease have been given the green light by UK regulators. Donanemab and lecanemab are the first treatments found to slow progression of the disease. Donanemab has just been approved for use in Australia, however is not yet available on the Pharmaceutical Benefits Scheme. Lecanemab has not received approval. Both have also been blocked for use on Britain's National Health Service, on the grounds they are not cost-effective. Experts believe that diagnosing dementia early is key to making treatments more effective and helping to ensure they become more widely available. Almost 1 million people in Britain are living with dementia, but this number is expected to reach 1.4 million by 2040. About 400,000 people have dementia in Australia. Oxford Brain Diagnostics, a spinout company from the University of Oxford, was founded by Dr Steven Chance, former associate professor of neuroscience at Oxford, and Professor Mark Jenkinson, a leading expert in brain imaging. Loading The breakthrough was achieved after the company received funding from British investment firm BGF and the Oxford Technology & Innovations Fund. Identify other neurodegenerative conditions Studies have found the method can detect neurodegenerative changes before any visible brain shrinkage or atrophy appears on standard imaging as well as distinguish between different types of dementia. It has also been found to predict which individuals with mild cognitive impairment are more likely to develop dementia. The platform could also help to identify other neurodegenerative conditions including Parkinson's disease and multiple sclerosis. Chance said: 'The core technology is founded on my background, looking at the microscopic structure of brains at autopsy for many years. You couldn't do that with a living patient and this is what we needed.' He said the technology could have a transformative impact, bringing hope to 'millions of people who are seeking a non-invasive, precision diagnostic tool to reveal the truth about their brain health'. For now, the target patient market is those suffering mild cognitive decline, allowing professionals to differentiate between types of dementia and other neurodegenerative diseases. Chance said clinics might offer annual checks for those with concerns about memory problems. In time, and with the advent of more medicines to treat dementia, such advances could be rolled out to those in mid-life, he said. 'More than 20 per cent of those over 50 have Alzheimer's-type changes, small-scale changes that would be otherwise invisible. These breakthroughs open up a whole new way of monitoring brain health.' Alzheimer's Research UK policy head David Thomas said: 'Dementia is caused by diseases that often begin years before symptoms appear, and so finding new ways to detect these diseases earlier is vital. There is a huge amount of progress happening in this space and it's encouraging to see UK companies contributing to that. 'While this technology shows promise for diagnosing dementia earlier, so far it has only been validated in research settings. We're still some way off it being used within the NHS and we would need to see much more real-world clinical data to fully understand its potential. Loading 'Improving early and accurate diagnosis is crucial – not only to give people clarity about their condition but also to ensure they can access the right support and, in future, new treatments as they become available.' The Telegraph, London
Sydney Morning Herald
25-05-2025
- Health
- Sydney Morning Herald
Brain scan to detect Alzheimer's before symptoms appear is world first
It has already been designated by the US Food and Drug Administration for use in the United States as a 'breakthrough' device. The neuroscientist behind the advances said it meant medical professionals were able to see changes in the brain far earlier, at a level normally only be possible via a post-mortem examination. Over the past year, two major treatments for Alzheimer's disease have been given the green light by UK regulators. Donanemab and lecanemab are the first treatments found to slow progression of the disease. Donanemab has just been approved for use in Australia, however is not yet available on the Pharmaceutical Benefits Scheme. Lecanemab has not received approval. Both have also been blocked for use on Britain's National Health Service, on the grounds they are not cost-effective. Experts believe that diagnosing dementia early is key to making treatments more effective and helping to ensure they become more widely available. Almost 1 million people in Britain are living with dementia, but this number is expected to reach 1.4 million by 2040. About 400,000 people have dementia in Australia. Oxford Brain Diagnostics, a spinout company from the University of Oxford, was founded by Dr Steven Chance, former associate professor of neuroscience at Oxford, and Professor Mark Jenkinson, a leading expert in brain imaging. Loading The breakthrough was achieved after the company received funding from British investment firm BGF and the Oxford Technology & Innovations Fund. Identify other neurodegenerative conditions Studies have found the method can detect neurodegenerative changes before any visible brain shrinkage or atrophy appears on standard imaging as well as distinguish between different types of dementia. It has also been found to predict which individuals with mild cognitive impairment are more likely to develop dementia. The platform could also help to identify other neurodegenerative conditions including Parkinson's disease and multiple sclerosis. Chance said: 'The core technology is founded on my background, looking at the microscopic structure of brains at autopsy for many years. You couldn't do that with a living patient and this is what we needed.' He said the technology could have a transformative impact, bringing hope to 'millions of people who are seeking a non-invasive, precision diagnostic tool to reveal the truth about their brain health'. For now, the target patient market is those suffering mild cognitive decline, allowing professionals to differentiate between types of dementia and other neurodegenerative diseases. Chance said clinics might offer annual checks for those with concerns about memory problems. In time, and with the advent of more medicines to treat dementia, such advances could be rolled out to those in mid-life, he said. 'More than 20 per cent of those over 50 have Alzheimer's-type changes, small-scale changes that would be otherwise invisible. These breakthroughs open up a whole new way of monitoring brain health.' Alzheimer's Research UK policy head David Thomas said: 'Dementia is caused by diseases that often begin years before symptoms appear, and so finding new ways to detect these diseases earlier is vital. There is a huge amount of progress happening in this space and it's encouraging to see UK companies contributing to that. 'While this technology shows promise for diagnosing dementia earlier, so far it has only been validated in research settings. We're still some way off it being used within the NHS and we would need to see much more real-world clinical data to fully understand its potential. Loading 'Improving early and accurate diagnosis is crucial – not only to give people clarity about their condition but also to ensure they can access the right support and, in future, new treatments as they become available.' The Telegraph, London
New Straits Times
22-05-2025
- Health
- New Straits Times
Australia approves first drug for treatment of Alzheimer's disease
ANKARA: Australia's drug and therapeutic regulatory agency has approved the first drug for the treatment of Alzheimer's disease, Anadolu Ajansi reported, citing public broadcaster ABC. The Therapeutic Goods Administration (TGA) approved the drug, Donanemab, which has been found to slow the progression of Alzheimer's by clearing proteins in the brain. The drug is intended for those with mild cognitive impairment or mild dementia due to Alzheimer's, which is the most common type of dementia. It is the leading cause of death for Australian women and the second most common for men. The drug is administered as an intravenous infusion through the arm every four weeks for a maximum of 18 months. Clinical trials have shown it can help in the early stages of Alzheimer's disease. It is, however, not a cure and does not stop cognitive decline. But it can slow the disease and allow people to enjoy a better quality of life for longer. The drug, which is already approved in the UK and US, is not listed on the Pharmaceutical Benefits Scheme at this stage, meaning it is not subsidised by the government and will cost anywhere between $40,000 and $80,000 a year to administer. Health experts, however, caution about side effects such as brain swelling and bleeding, calling for close monitoring. – Bernama-Anadolu
Daily Mail
22-05-2025
- Health
- Daily Mail
Miracle for Australians with Alzheimer's disease as new medication is approved
Australia has approved a new drug for the treatment of early Alzheimer's disease for the first time in 25 years. The Therapeutic Goods Administration has approved Donanemab for those suffering mild cognitive impairment or mild dementia due to the condition. While the drug is not a cure for the disease, it slows the progression of Alzheimer's by clearing a build-up of abnormal proteins in the brain which can cause memory loss and impaired thinking. Donanemab is given to patients as a 30-minute infusion through the arm every four weeks for a maximum of 18 months. However, the drug has not been listed on the Pharmaceutical Benefits Scheme. That means Donanemab is not subsidised by the government and can cost patients anywhere from $40,000 to $80,000 a year. Melbourne grandparents Joel Fulton, 67, and his wife and carer Diane Fulton, 64, said having access to the drug could change their lives. Mr Fulton spent his life working in the book industry before he was forced into early retirement in 2023 after being diagnosed with early symptomatic Alzheimer's disease the year prior. 'Memory was a huge part of my working life in the book trade. After being in the industry for over 40 years, I became the go-to person in my field,' he said. 'I also needed to memorise and confidently sell new lists from publishers every month. Then, slowly but surely, it was as if my memory was being wiped. 'I was aware of this happening but there was nothing I could do to stop it.' Ms Fulton, who now cares for her husband full-time, recalled his diagnosis as 'the rug being pulled from underneath him'. 'Joel gradually lost all confidence in himself. He's a very different man now, compared to the man he was prior to his diagnosis,' she said. 'Joel has lost the ability to complete many daily tasks independently. He has had to stop driving, which has had a huge impact on him. 'As his wife and full-time carer, I try to keep things as normal as possible with prompts and boards everywhere to help him, but he relies on me being with him and keeping him on track.' While Mr Fulton's quality of life has already deteriorated, he and his wife believe access to affordable Donanemab treatment could help them enjoy their golden years. 'If I could access this new medicine, I would in a heartbeat,' he said. Ms Fulton added: 'We need it now, before Joel's symptoms get much worse, and so that he can get the most benefit from the drug to give us more quality time together.' Nearly 1.6million Australians are involved in the care of someone living with dementia. Ms Fulton said it's the 'little things' that make caring for her husband so heartbreaking. 'Joel goes to the shed to get a screwdriver, then comes back empty handed. This will happen four or five times until he throws his hands up in frustration,' she said. 'We'll go somewhere like the shops or the doctor's, and he will think he hasn't been there for years even though it may have been a week or so since we were there. 'It was Mother's Day recently and he thought it was Christmas. 'When we got engaged, we thought we'd be together for 99 years with an option for 99 more. We joked about wheelchair races along the Yarra. We never could have imagined this.' Around 600,000 Australians are currently living with Alzheimer's disease, with approximately 450,000 of those in its early stages. General Manager of Lilly, a pharmaceuticals company, Tori Brown believes the registration of Donanemab '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,' she said. A reimbursement application to include Kisunla, a brand of Donanemab by Lilly, on the Pharmaceutical Benefits Scheme will be reviewed by the Pharmaceutical Benefits Advisory Committee in July.
