Latest news with #MetabolicDysfunction-AssociatedSteatohepatitis
Indian Express
06-05-2025
- Health
- Indian Express
Explained: ‘Wonder drug' Ozempic could reverse liver disease, finds study
A drug originally developed to treat diabetes, and now prescribed for weight loss, may have yet another significant application: stopping, perhaps even reversing, liver disease. In a phase 3 clinical trial involving 800 participants across 37 countries, and lasting 72 weeks, an international team of researchers found that a weekly dose of semaglutide was effective at treating Metabolic Dysfunction-Associated Steatohepatitis (MASH), a serious form of fatty liver disease, in almost two-thirds of patients. Semaglutide is the key component of diabetes drug Ozempic and weight loss drug Wegovy. The study was led by Dr Arun Sanyal of the Virginia Commonwealth University (US), and Dr Philip Newsome of King's College London. Its findings were published on April 30 in The New England Journal of Medicine. 'The results provide strong evidence that semaglutide can help by not only improving liver health, but also addressing the underlying metabolic issues that contribute to the disease,' Sanyal said in a press release by his university. According to Yale Medicine, MASH describes a spectrum of conditions marked by fat buildup in the liver not caused by alcohol use. It is a metabolic syndrome usually caused by overnutrition, and leads to inflammation and scarring of the liver. 'If approved, (the use of semaglutide to treat MASH) could offer an additional therapeutic option… This is crucial, given the strong link between MASH and cardiovascular, metabolic, and renal conditions, where semaglutide has already shown established health benefits,' Sanyal said.
Yahoo
02-05-2025
- Health
- Yahoo
Health Canada accepts semaglutide 2.4 mg, a GLP-1RA treatment for MASH, as a supplemental New Drug Submission under the Priority Review Policy
It is estimated that by 2030 the prevalence of MASH (Metabolic Dysfunction-Associated Steatohepatitis) in the Canadian general population will increase from 5.2% to 6.5%.1 Left untreated, MASH can progress to serious and even fatal outcomes, such as cirrhosis, liver cancer, and the need for liver transplant.2 MISSISSAUGA, ON, May 2, 2025 /CNW/ - Today, Novo Nordisk Canada announced that Health Canada has accepted for review, under the Priority Review policy, its supplemental new drug submission (sNDS) for semaglutide 2.4 mg, a once weekly therapy for people living with MASH (metabolic dysfunction-associated steatohepatitis). "Semaglutide 2.4 mg represents a therapeutic advancement for patients living with MASH, addressing a critical unmet medical need," says Vince Lamanna, President of Novo Nordisk Canada Inc. "Health Canada's acceptance of the Semaglutide 2.4 mg submission for review brings us one step closer to providing the first treatment option for eligible people living with MASH." About semaglutide 2.4 mgSemaglutide injection 2.4 mg is currently approved by Health Canada for chronic weight management and non-fatal myocardial infarction (MI) risk reduction in adults with established cardiovascular disease and BMI ≥ 27 kg/m2.3 Semaglutide is not approved in Canada for the treatment of MASH. Safety and efficacy are not established, and there is no guarantee that semaglutide will become commercially available for this use under clinical investigation. About Metabolic Dysfunction-Associated Steatohepatitis (MASH) MASH is a chronic, progressive metabolic disease affecting the liver, which can be potentially life-threatening if not properly managed.4,5 Among people who are living with overweight or obesity, approximately one in three also have MASH.6 Excess fat can build up in the liver, which, over time, can lead to inflammation and severe scarring of the liver.7 People living with MASH often experience few or no specific symptoms in the early stages of the disease, which often results in a delayed diagnosis.8 It is estimated that by 2030 the prevalence of MASH in the Canadian general population will increase from 5.2% to 6.5%.1 In Canada, the number of deaths are expected to double in people living with MASH by 2030.1 About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. _______________________________ 1 Swain M et al. CMAJ Open 2020;8:E429-E436. CMA open, 8(2), June 2020 2 Fichez J, Mouillot T, Vonghia L, et al. Non-invasive tests for fibrotic MASH for reducing screen failure in therapeutic trials. JHEP Reports. 2025;7(4);101351. doi:10.1016/ 3 Novo Nordisk Canada Inc. (2025, April 8). Wegovy® Product Monograph. 4 Ilan Y. Analogy between non-alcoholic steatohepatitis (NASH) and hypertension: a stepwise patient-tailored approach for NASH treatment. Ann Gastroenterol. 2018;31:296-304. doi:10.20524/aog.2018.0248 5 Tesfay M, Goldkamp JW, Neuschwander-Tetri BA. NASH: the emerging most common form of chronic liver disease. Mo Med. 2018;115:225-229 6 Quek J, Chan KE, Wong ZY, et al. Global prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in the overweight and obese population: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023;8:20-30. doi: 10.1016/S2468-1253(22)00317-X 7 National Institute of Diabetes and Digestive and Kidney Diseases. Definition & facts of NAFLD & NASH. Accessed November 7, 2024. Available at: 8 Allen AM, Charlton M, Cusi K, et al. Guideline-based management of metabolic dysfunction-associated steatotic liver disease in the primary care setting. Postgrad Med. 2024;136:229-245. doi:10.1080/00325481.2024.2325332 SOURCE Novo Nordisk Canada Inc. View original content to download multimedia: Sign in to access your portfolio
Cision Canada
02-05-2025
- Health
- Cision Canada
Health Canada accepts semaglutide 2.4 mg, a GLP-1RA treatment for MASH, as a supplemental New Drug Submission under the Priority Review Policy
It is estimated that by 2030 the prevalence of MASH (Metabolic Dysfunction-Associated Steatohepatitis) in the Canadian general population will increase from 5.2% to 6.5%. 1 Left untreated, MASH can progress to serious and even fatal outcomes, such as cirrhosis, liver cancer, and the need for liver transplant. 2 MISSISSAUGA, ON, May 2, 2025 /CNW/ - Today, Novo Nordisk Canada announced that Health Canada has accepted for review, under the Priority Review policy, its supplemental new drug submission (sNDS) for semaglutide 2.4 mg, a once weekly therapy for people living with MASH (metabolic dysfunction-associated steatohepatitis). "Semaglutide 2.4 mg represents a therapeutic advancement for patients living with MASH, addressing a critical unmet medical need," says Vince Lamanna, President of Novo Nordisk Canada Inc. "Health Canada's acceptance of the Semaglutide 2.4 mg submission for review brings us one step closer to providing the first treatment option for eligible people living with MASH." About semaglutide 2.4 mg Semaglutide injection 2.4 mg is currently approved by Health Canada for chronic weight management and non-fatal myocardial infarction (MI) risk reduction in adults with established cardiovascular disease and BMI ≥ 27 kg/m 2. 3 Semaglutide is not approved in Canada for the treatment of MASH. Safety and efficacy are not established, and there is no guarantee that semaglutide will become commercially available for this use under clinical investigation. About Metabolic Dysfunction-Associated Steatohepatitis (MASH) MASH is a chronic, progressive metabolic disease affecting the liver, which can be potentially life-threatening if not properly managed. 4, 5 Among people who are living with overweight or obesity, approximately one in three also have MASH. 6 Excess fat can build up in the liver, which, over time, can lead to inflammation and severe scarring of the liver. 7 People living with MASH often experience few or no specific symptoms in the early stages of the disease, which often results in a delayed diagnosis. 8 It is estimated that by 2030 the prevalence of MASH in the Canadian general population will increase from 5.2% to 6.5%. 1 In Canada, the number of deaths are expected to double in people living with MASH by 2030. 1 About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. SOURCE Novo Nordisk Canada Inc.
Yahoo
02-05-2025
- Health
- Yahoo
Landmark Study Finds Semaglutide Effectively Treats Serious Liver Disease
Semaglutide is the key component of weight loss and diabetes drugs like Ozempic and Wegovy, and an international team of researchers has now discovered it can also do wonders for people who have developed liver disease. In a phase 3 clinical trial involving 800 participants and lasting 72 weeks, a weekly dose of semaglutide was effective in almost two-thirds of patients at treating a serious form of fatty liver disease known as Metabolic Dysfunction-Associated Steatohepatitis (MASH). "The results from this landmark study across 37 countries provide strong evidence that semaglutide can help patients with MASH by not only improving liver health, but also addressing the underlying metabolic issues that contribute to the disease," says Arun Sanyal, a professor of medicine at Virginia Commonwealth University. The participants were split into two groups. Of those given the semaglutide treatment, 62.9 percent saw improvements in their MASH, compared to 34.3 percent of the group given a placebo treatment instead. What's more, liver fibrosis (scarring) – which happens as the liver tries to repair damage – was reduced in 36.8 percent of patients given the semaglutide treatment, compared to 22.4 percent of patients given placebos. Improvements in both MASH and fibrosis were seen in 32.7 percent of the participants on semaglutide, compared to 16.1 percent of the placebo group. It's a comprehensive win for the drug, which is showing potential in many different areas of health. That placebo effect is fairly typical, by the way, and often happens in trials: it's thought to be a combination of the psychological boost of thinking you're being treated, plus a tendency to live more healthily and carefully if you know you're part of a study. "If approved, this could offer an additional therapeutic option for patients with MASH and fibrosis," says Sanyal. "This is crucial, given the strong link between MASH and cardiovascular, metabolic, and renal conditions, where semaglutide has already shown established health benefits." Semaglutide is a GLP-1 (glucagon-like peptide-1) receptor agonist, essentially acting like the natural GLP-1 hormone to help regulate key metabolic processes – including reducing appetite and lowering blood sugar. That makes it effective for treating obesity and diabetes, but this boost in biological regulation seems to have plenty of other benefits too. When it comes to liver disease, the thinking is that the metabolism and anti-inflammatory improvements triggered by the drug help to treat some of the key drivers of MASH. This clinical trial is continuing, expanding to a larger group of people for a full five years to see if these initial improvements continue. With only one approved treatment available for MASH, new options are urgently needed. "By treating both liver disease and its metabolic causes, semaglutide offers a promising new approach for millions of patients," says Sanyal. The research has been published in the New England Journal of Medicine. Alzheimer's Could Be Linked to a Common Virus You Already Have Common Gut Fungus May Protect Against Fatty Liver Disease, Study Finds Whooping Cough Is on The Rise: An Expert Explains How to Protect Your Family
Associated Press
18-03-2025
- Health
- Associated Press
A New Standard in Clinical Care for MASH Patients: HistoIndex Launches FibroSIGHT™
SINGAPORE, March 17, 2025 /PRNewswire/ -- HistoIndex, a global leader in stain-free digital pathology solutions for managing fibrotic diseases, has announced the launch of their first Laboratory Developed Test (LDT) FibroSIGHT™ – now available in the United States. This marks a significant milestone for HistoIndex as the company enters clinical care for patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH). 'I am excited to see how our core expertise in clinical trial assessments is now transcending into the realm of precise and personalized patient care,' said Dr. Gideon Ho, Chief Executive Officer of HistoIndex.' With FibroSIGHT, we aim to empower clinicians with a more definitive and accurate assessment of liver fibrosis.' MASH has long been a challenging and progressive liver disease, characterized by fat build-up and inflammation that, if left untreated, leads to fibrosis and, ultimately, cirrhosis. After decades of research and therapeutic development, the field reached a pivotal moment in 2024 with the approval of Rezdiffra® - the first drug for the treatment of MASH with moderate to advanced fibrosis[1,2*]. As treatment options expand, accurate fibrosis assessment becomes even more critical in guiding clinical decisions and optimizing patient outcomes. HistoIndex has been playing a key role in the development of MASH treatments and is now leading the way in this next phase of patient care with FibroSIGHT. FibroSIGHT seamlessly integrates into routine clinical workflows, leveraging on HistoIndex's proprietary stain-free imaging technology to enhance the sensitivity of fibrillar collagens detection — key in evaluating fibrosis severity in liver biopsy samples (see Figure 1). By eliminating variability associated with traditional staining techniques, FibroSIGHT delivers reliable and precise fibrosis assessment for MASH patients. Clinicians can now order FibroSIGHT for MASH patients, on whom liver biopsies were performed, whenever definitive and accurate assessments of fibrosis are needed[2,3]. This includes use at the time of diagnosis to determine treatment decisions, when non-invasive assessments of degree of fibrosis are either inconclusive or discordant. Additionally, FibroSIGHT can be ordered post treatment to evaluate patients' response, especially in cases where there are no apparent improvement. 'By providing more accurate and objective evaluation of fibrosis, FibroSIGHT will enable more personalized treatment strategies and better evaluations of effectiveness of treatment leading to overall better care for patients,' commented Dr Naim Alkhouri, MD, Chief Medical Officer of Arizona Liver Health. 'Where biopsy evaluation is needed for a MASH patient, I can see incorporating FibroSIGHT in the workup, and in doing so, benefiting the entire MASH clinical care community.' FibroSIGHT testing is performed in HistoIndex's CAP/CLIA accredited laboratory in Irvine, California. With the launch of FibroSIGHT, HistoIndex reaffirms its long-standing commitment in advancing fibrosis assessment and personalized treatment for MASH. By bridging research with clinical care, FibroSIGHT empowers informed treatment decisions, driving better patient care in the evolving landscape of liver disease management. About MASH Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive form of Metabolic dysfunction-associated steatotic liver disease (MASLD) characterized by steatosis and inflammation, which can lead to fibrosis (scarring), cirrhosis, liver failure, and an increased risk of liver cancer. The presence of ballooned hepatocytes (enlarged and damaged liver cells) is a key feature distinguishing MASH from simple steatosis. Pathologist assessments of liver biopsy remain the gold standard for diagnosing and assessing the severity of MASH. Histological categorial scoring systems are often used as surrogate endpoints to evaluate drug efficacy in clinical trials. These endpoints are limited in capturing the complex and heterogeneous nature of the disease. As a result, there is a growing need for more accurate and reliable tools, such as AI-based digital pathology solutions, to improve the assessment of treatment response and disease severity in MASH. About HistoIndex Founded in 2010, HistoIndex pioneers in stain-free, fully automated imaging solutions for visualizing and quantifying fibrosis in biological tissues. By combining cutting-edge biophotonic technology with AI-based analysis, HistoIndex provides innovative tools to improve the assessment of fibrosis changes and drug efficacy. HistoIndex's breakthrough digital pathology solutions are currently used in accelerating clinical research, expediting pharmaceutical drug development, and transforming medical standards.
