Latest news with #Kisunla
Yahoo
29-05-2025
- Business
- Yahoo
Helix releases pharmacogenomics tests for use in neurology and oncology
US-based genomics company Helix has released a new suite of pharmacogenomics (PGx) tests, widening its portfolio to offer personalised patient care in neurology and oncology. The suite includes a PGx Fluoropyrimidines DPYD test to detect individuals with dihydropyrimidine dehydrogenase (DPYD) gene variants at risk for side effects from certain chemotherapies, aligning with the recent guidelines from the National Comprehensive Cancer Network. The DPYD test provides insights into a patient's metabolism of cancer treatments. It targets therapies used in treating breast, pancreatic, head and neck, colorectal, and oesophageal cancers. Additionally, the suite includes the PGx APOE test to evaluate the status of apolipoprotein E (APOE) relevant to Alzheimer's drugs. It assesses the risk of serious adverse effects such as amyloid-related imaging abnormalities (ARIA) for individuals treated with Leqembi or Kisunla. These drugs have US Food and Drug Administration (FDA) boxed warnings for individuals with two copies of the APOE ε4 allele. With these tests, Helix now covers all neurology and oncology-associated PGx haplotypes cited in the agency's warnings. The company noted that its PGx tests offer accuracy across varied populations, utilising its Exome+ assay and comprehensive star allele caller. Its Sequence Once, Query Often model allows for exomes to be sequenced just once, with subsequent genetic tests not requiring additional samples. This facilitates rapid results, enabling genetic insights at the point of care. Helix's latest PGx tests encompass medications for cancer, cardiovascular diseases, pain management, gastrointestinal conditions, and anaesthesia guidance. These tests add to the company's existing PGx offerings for blood clotting, mental health, and immune suppression treatments. In addition, Helix has also developed the Helix Research Network in collaboration with its partners. This precision clinical research network comprises health systems focused on integrating genomics into routine care and advancing human health through genomics research. It also creates real-world evidence to support a wide range of initiatives, including studies showing the genomics' clinical use. Helix chief science officer Will Lee said: 'By focusing on patients with neurodegenerative conditions and cancer, and actively identifying those at higher risk for adverse outcomes, we can help providers treat vulnerable patients more precisely and effectively.' "Helix releases pharmacogenomics tests for use in neurology and oncology" was originally created and published by Medical Device Network, 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
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
ABC News
22-05-2025
- Health
- ABC News
New Alzheimer's drug approved in Australia
Andy Park: A new drug promising to treat the early stages of Alzheimer's disease has been approved for use in Australia, the first of its kind in nearly 25 years. Donanemab , sold under the brand name Kisunla, is a medication which can potentially slow the progress of the disease and maintains a patient's independence. However, there have been some concerns about the drug's effectiveness overseas and its high cost, as Kimberley Price reports. Kimberley Price: It starts with forgotten names and missed appointments, but eventually takes away your ability to carry out even simple tasks. More than 400,000 Australians live with dementia, with Alzheimer's disease the most common type. For two decades, there has been little progress in treating it. But today, a new drug has arrived which may change that. Michael Woodward: This is a significant breakthrough. It's the first time we have a disease-modifying drug for Alzheimer's disease. Kimberley Price: That's Associate Professor Michael Woodward, head of dementia research at the Memory Clinic at Austin Health in Melbourne. The drug he's talking about is Denanimab, a medicine which clears away amyloid plaques, the molecules which are believed to cause the symptoms of Alzheimer's. Michael Woodward: So it means that people will deteriorate more slowly because the amyloid sets off a process that causes the symptoms of forgetfulness and loss of our ability to look after ourselves. So if we use this drug, particularly in the earlier stages of Alzheimer's disease, we can't completely cure the disease, but we can slow it down substantially. Kimberley Price: Donanemab has some major limitations. It can cause swelling or bleeding in the brain, which can be life-threatening. And those taking the drug require regular MRI scans to monitor for side effects. It's also only approved for use in patients in the early stages of Alzheimer's who are dealing with initial memory loss and mood changes. Michael Woodward: It's not approved for moderate or severe dementia due to Alzheimer's disease because unfortunately by then the amyloid has done too much damage. We need to remove the amyloid and stop the other cascade of Alzheimer's pathology at an early stage if possible and that's where this drug has been approved. Kimberley Price: Sydney-based geriatrician Professor Peter Gonski believes Donanemab needs to be used as part of a larger treatment plan. Peter Gonski: We do have to see the patient as a person and we need to treat them looking at a whole lot of different strategies in trying to improve their lives and continue their good quality life as long as possible. And I think that this is a very important addition to our treatment plan. Kimberley Price: And while the drug has limitations, Professor Gonski says it's an important new tool. Peter Gonski: We have not really had medication development for 25 to 30 years and although we have had some medications that have slowed down the progression of the condition, sometimes even improved people in the early stages, they really haven't changed the actual underlying pathology that occurs in Alzheimer's disease. They've basically changed the chemicals in the brain. Kimberley Price: While Donanemab has been approved by the TGA for use in Australia, it's currently not covered by the Pharmaceutical Benefits Scheme. While no price has been listed, in the US the drug costs the equivalent of $47,000 Australian dollars per year. Andy Park: That report by Kimberley Price and Luke Radford.
