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Time of India
18 hours ago
- Health
- Time of India
US FDA approves a weight loss drug for treating ‘serious' fatty liver disease; here's what you need to know
The US Food and Drug Administration (FDA) has officially approved semaglutide, a drug widely known for weight loss and diabetes control, for treating metabolic associated steatohepatitis (MASH). This approval marks a major advancement in liver disease treatment, as MASH is a progressive condition caused by fat buildup and inflammation in the liver. Often symptomless in its early stages, the disease can silently progress to cirrhosis, liver failure, or liver cancer if untreated. By targeting both weight reduction and liver health, semaglutide offers a dual benefit for patients at high risk. Experts see this as a breakthrough, providing the first effective pharmacological option for millions affected by fatty liver disease, which is rapidly emerging as a global health concern. These results suggest semaglutide is not just managing risk factors like weight and blood sugar but is directly improving liver health, offering new hope for patients who previously had no effective drug treatment options. What is the link between fatty liver and diabetes mellitus? What is MASH? Understanding the fatty liver disease MASH (previously called non-alcoholic steatohepatitis or NASH) is a severe form of fatty liver disease. It usually begins as metabolic-associated fatty liver disease (MAFLD), where fat gradually builds up in the liver due to poor metabolism. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Many Filipinos don't know about this! Read More Undo Early stage (MAFLD): Excess fat is stored in the liver but often without symptoms. Progression to MASH: Over time, fat accumulation triggers inflammation and cell injury. Advanced stage (Fibrosis and Cirrhosis): Continuous inflammation leads to scarring (fibrosis), which reduces liver function. Severe scarring, known as cirrhosis, may result in liver failure or cancer. Why early detection is difficult Most patients remain unaware of MASH because symptoms develop only in later stages. When present, they may include: Abdominal discomfort or pain Fatigue and low energy Loss of appetite and weight loss Jaundice (yellowing of eyes and skin) This makes screening and preventive treatment crucial, especially for people who are overweight, diabetic, or have high cholesterol. MASH and obesity: How Semaglutide is changing liver disease treatment MASH is closely linked to obesity, diabetes, and metabolic syndrome. With the rise of these conditions globally, MASH has become one of the leading causes of chronic liver disease. Until recently, doctors only recommended lifestyle interventions such as diet control, weight loss, and regular exercise. In 2023, the FDA approved Resmetirom, the first medicine for MASH. Now, semaglutide's approval adds another option — but with a different working mechanism. Semaglutide belongs to a class of drugs known as GLP-1 receptor agonists. It was first approved in 2017 for type 2 diabetes and later for obesity management and heart disease prevention. In MASH patients, semaglutide helps by: Reducing body weight and abdominal fat, which lowers liver fat storage Improving insulin resistance, a key factor in fatty liver buildup Lowering systemic inflammation, reducing liver injury This makes semaglutide particularly useful in patients who have both obesity and fatty liver disease. Source: The New York Times FDA approves semaglutide medication for MASH after strong clinical trial results The FDA based its approval on results from a large phase III clinical trial involving 800 participants across multiple centers. 534 patients received semaglutide; 266 received a placebo. After 72 weeks, results showed: 63% of patients on semaglutide had resolution of MASH without worsening liver scarring. Only 34% in the placebo group achieved the same. When looking at liver fibrosis (scarring): 37% of semaglutide users showed improvement, compared to 22% in the placebo group. The trial is ongoing for 240 weeks (around 4.5 years) to determine whether these improvements can lower risks of death, liver transplant, or severe complications. MASH in India: A growing health challenge India is witnessing a rapid increase in metabolic liver diseases, driven by rising obesity, sedentary lifestyles, and high rates of diabetes. As reported, studies estimate that 9% to 32% of Indians may be living with MAFLD, the starting point of MASH. A 2025 study of IT employees in Hyderabad revealed alarming trends: 84% had excess liver fat 76.5% had high cholesterol levels 70.7% were obese 20.9% had elevated fasting blood sugar These numbers reflect the strong connection between urban lifestyles, poor diet, and fatty liver disease in India's working population. Also Read |
Indian Express
2 days ago
- Health
- Indian Express
US FDA approves blockbuster weight loss drug for severe fatty liver disease: What this means for you?
The US Food and Drug Administration (FDA) has approved the popular weight-loss drug semaglutide for the treatment of the liver condition called metabolic associated steatohepatitis (MASH) — previously referred to as non-alcoholic steatohepatitis. It is a more severe form of non-alcoholic fatty liver disease, where the fat deposition on the liver leads to inflammation and liver cell damage. The medicine was first approved in 2017 for the treatment of diabetes. It has since been approved for the treatment of obesity and associated cardiovascular diseases. The condition starts off as non-alcoholic, or as it is now known metabolic-associated, fatty liver disease. This fat build-up, over time, leads to inflammation and scarring of the liver, reducing the efficiency of the organ. Importantly, it can further progress to severe scarring called cirrhosis and then liver cancer. The challenge is that most people remain unaware of the condition in the initial stages. It is only when there has been significant damage to the organ that people experience symptoms such as abdominal pain, fatigue and weakness, loss of appetite, weight loss, and jaundice (yellowing of the eyes and skin caused by bilirubin buildup when the liver does not function properly). With obesity on the rise, there has been an increase in the incidence of MASH. For most people diagnosed to have fat accumulation in the liver, doctors suggest diet and exercise as a means of reducing body fat as well as the fat deposition in the abdomen and various organs, including the liver. Yet, it was only last year that the very first treatment for the condition was approved by the US FDA. Resmetirom, along with diet and exercise, was shown to resolve MASH and prevent worsening of the liver scarring. It works by activating a receptor that controls processes such as lipid metabolism, thereby reducing fat in the liver and its inflammation. Semaglutide, on the other hand, works by addressing underlying risk factors such as obesity, abdominal deposition of fat, diabetes, and insulin resistance. A phase III trial of 800 people — randomly prescribed semaglutide (534 participants) or placebo (266 participants) — showed that 63 per cent receiving the drug saw resolution of MASH and no worsening of the liver scarring as compared to 34 per cent receiving placebo. The interim trial data also shows that 37 per cent of the participants on semaglutide showed improvement in liver scarring and no worsening of MASH as compared to 22 per cent receiving placebo at 72 weeks after initiating treatment. 'The trial will continue for a total of 240 weeks to determine whether inflammation and scarring improvements seen after 72 weeks translate into decreases in death, liver transplant and other liver-related events,' the FDA said in a statement. It is estimated that anywhere between nine per cent and 32 per cent of the population in India is living with metabolic associated fatty liver disease — the beginning stage of MASH. A study published earlier this year showed more than 84 per cent of the IT sector employees in Hyderabad had increased liver fat accumulation, indicating MAFLD. The study — based on data from 345 IT employees — found that 76.5 per cent had high levels of bad cholesterol, 70.7 per cent were obese, and 20.9 per cent had higher than normal fasting blood glucose levels.
Business Standard
29-04-2025
- Health
- Business Standard
Morepen receives CDSCO nod to conduct BE studies for Resmetirom
For treatment of liver disease Morepen Laboratories has got clearance from Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) to conduct Bioequivalence (BE) studies for Resmetirom 60 mg, 80 mg and 100 mg tablets as per the protocol submitted. This will be followed by clinical trials as per approved protocols. Resmetirom is a highly promising therapy under development for non-alcoholic steatohepatitis (NASH'), a serious form of non-alcoholic fatty liver disease (NAFLD) characterized by inflammation, liver damage, and fat accumulation in the liver, potentially leading to scarring (fibrosis), cirrhosis, and even liver cancer. It is often associated with obesity, metabolic syndrome, and type 2 diabetes, and while it can be a silent disease in the early stages, it can progress to severe liver damage if left untreated. As one of the first Indian companies to foray into this therapeutic area, Morepen is strategically positioned to serve both domestic and international markets and is also evaluating out-licencing opportunities with potential marketing partners.
Business Upturn
29-04-2025
- Business
- Business Upturn
Morepen Laboratories receives SEC clearance for Resmetirom bioequivalence studies
By Aman Shukla Published on April 29, 2025, 09:04 IST Morepen Laboratories Ltd. has received clearance from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to conduct bioequivalence (BE) studies for Resmetirom tablets in 60 mg, 80 mg, and 100 mg doses. The approval is based on the protocols submitted by the company. Following the successful completion of BE studies, Morepen will proceed with clinical trials as per approved protocols. Resmetirom is a therapy currently under development for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a progressive and serious form of non-alcoholic fatty liver disease (NAFLD), characterized by liver inflammation, fat accumulation, and potential progression to fibrosis, cirrhosis, or liver cancer. It is commonly associated with conditions like obesity, metabolic syndrome, and type 2 diabetes. In many cases, NASH remains asymptomatic until it advances to more severe stages of liver damage. By initiating work in this therapeutic area, Morepen becomes one of the early Indian companies developing treatments for NASH. The company is also exploring out-licensing opportunities with potential marketing partners to expand the reach of Resmetirom. According to industry estimates, the global NASH treatment market is projected to grow from approximately USD 2.5 billion in 2024 to over USD 16 billion by 2032. This growth is driven by rising disease prevalence, increased clinical awareness, and regulatory advancements worldwide. Morepen Laboratories has an established global presence, exporting active pharmaceutical ingredients (APIs) and finished formulations to over 80 countries, including regulated markets such as the United States, Europe, and Japan. Its manufacturing facilities comply with major international standards, including USFDA, EU-GMP, and WHO-GMP certifications. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Globe and Mail
14-02-2025
- Health
- Globe and Mail
Devonian Reports Positive Results in MASH Liver Study
Devonian Health Group Inc. (' Devonian ' or the ' Company ') ( TSXV: GSD; OTCQB: DVHGF), a clinical stage corporation focused on developing unique solutions to inflammatory diseases, today announced a potential expanded therapeutic application for Thykamine™, with compelling preclinical data results demonstrating proof of concept efficacy in a well-established animal model of MASH metabolic dysfunction-associated steatohepatitis (MASH). The study investigated the effects of Thykamine™ on liver disease progression in the widely used STAM mouse model of MASH/fibrosis at SMC Laboratories in Japan. In this model, diabetic mice were fed a high fat diet and rapidly to develop fatty liver disease caused by inflammation and a buildup of fat in the organ. Resmetirom, the first drug approved by US-FDA for the management of MASH, was used as positive control at an oral dose of 3.0 mg/kg once a day for 3 weeks. Thykamine™ administered orally, at doses of 0.5 mg/kg, 5.0 mg/kg and 50.0 mg/kg, once a day for 3 weeks provided a hepatoprotective effect preventing liver disease progression compared to the control group (vehicle). Specifically, Thykamine™ treatment resulted in a significant lowering of the liver NAFLD activity score (NAS), a composite measure of fatty liver disease composed of steatosis, inflammation and hepatocyte ballooning. The α-SMA, a marker used to evaluate liver fibrosis, was also significantly decreased. Thykamine™ treatment decreased liver type collagen type I expression, collagen type III score, F4/F80 expression, Ly-6G expression and MARCO (macrophage receptor with collagen structure) expression. The effects on these markers were comparable to the effects of Resmeritom. Overall, progression of liver fibrosis was reduced by Thykamine™ treatment. Gene expression analysis data should be released shortly. The complete MASH preclinical results are planned to be submitted for publication in 2025. 'We are delighted with the outcome of this preclinical study and look forward to sharing more detail in a planned upcoming scientific publication. The data demonstrate an exciting proof of concept data of Thykamine™ anti-inflammatory and anti-fibrotic effects in MASH. Historical preclinical and clinical studies of Thykamine™ have demonstrated its anti-inflammatory properties. The anti-fibrotic MASH data adds an important key complementary feature of Thykamine™ mechanism of action. In inflammatory diseases, fibrosis typically develops in response to repeated injuries or chronic inflammation. The MASH study demonstrates that Thykamine™ has anti-inflammatory and anti-fibrotic effects with the potential to target underlying disease pathology and therefore stop the progression of the disease', said Dr. Andre P. Boulet, PhD, Chief Scientific Officer of the Company. 'This is one more study in the arsenal of Thykamine™, demonstrating its multi targeting mode of action affecting the cytokines affecting inflammation, opening up a broad array of possible applications for our lead product in underserved auto immune inflammatory diseases, which now adds hepatic conditions to our other targets such as dermatology and IBD', said Luc Gregoire, president and CEO of the Company. About NAFLD/MASH 1,2 Nonalcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease with a worldwide prevalence of 20-30%. It is represented by fat accumulation in the liver, a condition that is commonly associated with features of the metabolic syndrome (MetS), such as obesity, type 2 diabetes, dyslipidemia, and hypertension. NAFLD progresses to metabolic dysfunction-associated steatohepatitis (MASH), the hallmarks of which are inflammation, hepatocellular ballooning, and subsequent worsening fibrosis. Left untreated, MASH can ultimately progress to cirrhosis of the liver and hepatocellular carcinoma, liver failure and death. About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian's SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in North America, Europe and Asia. About Devonian Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune inflammatory conditions with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription drugs for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian's focus is further supported by a U.S. Food and Drug Administration set of regulatory guidelines favoring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in Canada, under license from brand name pharmaceutical companies. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability 'from the seed to the pill'. Devonian is traded publicly on the TSX Venture Exchange (the 'Exchange') (TSXV: GSD) and on OTCQB exchange (OTCQB: DVHGF). For more information, visit References Ekstedt M, Nasr P and Kechagias S. Natural History of NAFLD/NASH. Curr Hepatology Rep. 16:391-397, 2017. Pierantonelli I. and Svegliati-Baroni G. Nonalcoholic Fatty Liver Disease: basic Pathogerenic Mechanisms in the Progression from NAFLD to NASH. Transplantation, 103(1): p e1-e13, 2019 Cautionary Note Regarding Forward-Looking Statements All statements, other than statements of historical fact, contained in this press release including but, not limited to those relating to the economical impact of clinical study, the efficiency of the high anti-inflammatory potency proven and the position of the Thykamine™ as a possible first line treatment of choice for several autoimmune conditions in the early stages of the disease and the reduced need for aggressive treatments with biologics and other immune modulators, that are associated with serious side effects and long term negative consequences, and, generally, the above 'About Devonian' and 'About Altius' paragraphs, which essentially describes the Corporation's outlook, constitute 'forward-looking information' or 'forward-looking statements' within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management's expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of Canada. The Corporation disclaims any intention or obligation to update or revise any forward-looking statements or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. Neither the Exchange nor its Regulation Services Provider (as that term is defined in policies of the Exchange) accepts responsibility for the adequacy or accuracy of this release.
