Latest news with #donanemab
The Independent
7 days ago
- Business
- The Independent
The surprising new effect scientists hope weight loss drugs will have on dementia
Clinical trials in 2025 are assessing 138 treatments for dementia and Alzheimer's, an 11 per cent increase from the previous year, offering "hope" for prevention and treatment. One trial is examining whether semaglutide, the active ingredient in weight loss drugs like Ozempic and Wegovy, can slow dementia progression. Experts suggest 2025 could be a "landmark year" due to four drugs in large clinical trials that aim to prevent dementia, not just treat it. The trials include drugs targeting amyloid protein build-up, a key characteristic of Alzheimer's, with the aim of providing treatments earlier to those with a genetic risk. The National Institute for Health and Care Excellence (NICE) is reviewing donanemab and lecanemab, previously deemed not cost-effective, with a decision expected in the summer.
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)
Yahoo
23-05-2025
- Health
- Yahoo
‘Hope': Huge leap in dementia treatment
The Therapeutic Goods Administration has approved a new drug tipped to revolutionise the treatment of hundreds of thousands of Australians suffering through early-stage Alzheimer's disease. The breakthrough therapy called Kisunla, also known as donanemab, is designed to slow cognitive decline in patients by clearing amyloid plaques from the brain. Frank Freschi, 77, from Melbourne, took the treatment as part of a clinical trial and said he hoped the drug could give him more time to enjoy with his grandchildren. 'I used to be able to remember lots of things, now I can remember what I did 40 years ago but not what I did 40 hours ago,' he said. 'Accessing an amyloid targeting therapy has meant holding onto the hope that I'm a little bit in control of my life, of what's happening to me. 'I'm also hoping that one day I will have helped medical science to produce a drug that will work for many people. 'And, selfishly, that I too may be able to get some more time out of it to enjoy with my family and my six grandkids.' The TGA approved the drug, produced by US pharmaceutical behemoth Eli Lilly, on Wednesday, marking the first new treatment for early Alzheimer's disease in 25 years. Alzheimer's is a fatal neurodegenerative disease and the most common cause of dementia, which impacts about 600,000 Australians directly and a further 1.7 million carers. The economic impact of dementia from Alzheimer's was calculated at $8.1bn in 2024, with the figure expected to double by 2050. The excessive build-up of amyloid plaques in the brain disrupts the brain's neurons and prevents messages from travelling normally, leading to memory and thinking issues. Professor Peter Gonski, a Sydney-based geriatrician and Alzheimer's specialist, told NewsWire the treatment could potentially give two years back to patients. 'For those starting to deteriorate, it will give them an extra couple of years in benefit in those that do well on it,' he said. 'You're getting a better start in your dementia history.' Professor Gonski stressed, however, the treatment could slow decline but would not cure the disease. 'When it gets to moderate or severe, it's not going to make a lot of difference, except that you have had that extra time when you were better,' he said. Patients receive an intravenous injection of the drug once every four weeks. Dementia Australia chief executive Tanya Buchanan said the TGA's approval marked a 'step forward' in dementia treatment, but the treatment would only impact a select profile of patients. '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. '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.' Eli Lilly, a $1 trillion company listed on the New York Stock Exchange, will apply for donanemab to be included on the Pharmaceutical Benefits Scheme, with an advisory committee hearing expected in July. The private prescription price is about $4700 for each injection.
Yahoo
23-05-2025
- Health
- Yahoo
Eli Lilly and Company (LLY) Gains Approval in Australia for Early Alzheimer's Treatment
Eli Lilly and Company (NYSE:LLY) recently announced that Australia's Therapeutic Goods Administration (TGA) has approved Kisunla (donanemab) for marketing. The drug, administered via intravenous infusion every four weeks, is intended to treat adults with mild cognitive impairment or mild dementia caused by Alzheimer's disease, specifically those who are either non-carriers or have a single ApoE ε4 gene. Kisunla stands out as the first amyloid-targeting Alzheimer's therapy approved in Australia. It's also the only treatment of its kind supported by clinical evidence, allowing patients to stop treatment once amyloid plaques are cleared. However, medical experts have noted that fewer than 20% of dementia patients are likely to qualify for the therapy, which may cost patients over $80,000 out of pocket. Professor Christopher Rowe, head of the Australian Dementia Network, emphasized the significance of the approval, noting that it's the first Alzheimer's treatment in 25 years to impact disease progression. While older medications only temporarily eased symptoms, Kisunla has shown it can slow cognitive decline by roughly 33%. That said, the drug comes with risks. It has been linked to brain swelling and bleeding, particularly in individuals carrying two ApoE ε4 genes. According to Eli Lilly and Company (NYSE:LLY)'s release, around 600,000 Australians are currently living with Alzheimer's, with about 450,000 in the early stages who might be evaluated for Kisunla treatment. Alzheimer's remains the third leading cause of death in the country. While we acknowledge the potential of LLY to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than LLY and that has 100x upside potential, check out our report about this cheapest AI stock. READ MORE: and Disclosure. None.
Yahoo
22-05-2025
- Health
- Yahoo
Lilly's Kisunla marketing for Alzheimer's authorised in Australia
Eli Lilly and Company has received marketing authorisation from the Australian Therapeutic Goods Administration (TGA) for Kisunla (donanemab) to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in the adult population. This authorisation allows for the intravenous infusion of Kisunla every four weeks to treat the condition. The drug is specifically indicated for those who are Apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Kisunla is be the first amyloid-targeting therapy for Alzheimer's registered in the country. Kinsunla can reduce amyloid plaques, created by the clumping of naturally occurring amyloid proteins, potentially slowing the functional and cognitive decline in those with early symptomatic Alzheimers's. The decision to register the therapy was supported by data from the Phase III TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 trials. The TRAILBLAZER-ALZ 2 trial showcased the therapy's efficacy, slowing cognitive and functional decline against a placebo at 18 months and minimising disease progression risk by 39% over the same time. The approved titration schedule in the country, based on the TRAILBLAZER-ALZ 6 trial, significantly minimises the incidence of amyloid-related imaging abnormalities (ARIA) with oedema/effusion at 24 weeks against the original dosing schedule while maintaining Kisunla's plaque-reducing and plasma P-tau217-lowering abilities. Eli Lilly has also submitted this modified schedule for regulatory review in other countries. Kisunla has been approved in Australia, Bahrain, Brazil, China, Japan, Kuwait, Mexico, Qatar, Singapore, Taiwan, the UK, the United Arab Emirates and the US. Eli Lilly and Company executive vice-president and Lilly International president Ilya Yuffa stated: "It is exciting to see Kisunla's marketing authorisation in Australia, marking it as the 13th regulatory authorisation. 'In our TRAILBLAZER-ALZ 2 Phase III study, results showed that Kisunla significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer's, which allowed them more time to do things that mattered most to them, like remember information, make meals, manage finances and maintain independence.' Eli Lilly had previously announced an expansion of its partnership with Purdue University, with a planned investment of up to $250m over the next eight years to accelerate innovation across the pharma pipeline. "Lilly's Kisunla marketing for Alzheimer's authorised in Australia" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
