Latest news with #AmericanLiverFoundation
Al Arabiya
17 hours ago
- Health
- Al Arabiya
Novo Nordisk's Wegovy gets accelerated US approval for liver disease MASH
Novo Nordisk said on Friday the US Food and Drug Administration has granted accelerated approval for its weight-loss drug Wegovy to treat a serious liver condition called metabolic dysfunction-associated steatohepatitis, strengthening its presence in the metabolic disease market. The approval makes Wegovy the first GLP-1 class therapy cleared for MASH, a progressive liver condition that affects around 5 percent of adults in the United States, according to the American Liver Foundation. 'There really (have) not been good treatments in this space. We're only the second FDA-approved treatment for MASH, and we really need better medications that have better overall benefit-risk profiles, that really can also prevent the progression of the disease,' Jason Brett, principal US medical head at Novo Nordisk, said in an interview with Reuters. So far, the only available FDA-approved treatment for MASH is the Madrigal Pharmaceuticals drug Rezdiffra, which was approved in 2024. The FDA's decision was based on part one of an ongoing two-part study that showed Wegovy helped improve the organ's condition in more patients with MASH and liver scarring, compared to a placebo. Novo Nordisk said the drug is now available in the United States for adults with MASH and moderate to advanced liver scarring, and is to be used alongside proper diet and exercise. 'MASH patients need access to treatments - and that really can help them, especially early - to prevent it from progressing,' Brett said. 'We're doing as much as we can to work and partner with the payer community around enhancing access and reimbursement.' Brett did not provide any pricing details. Based on results from part one of the trial, Novo has applied this year for approval in Europe and Japan. Further results from part two of the trial are expected in 2029. Rival Eli Lilly's tirzepatide - the active ingredient in its popular diabetes drug Mounjaro and weight-loss treatment Zepbound - previously helped up to 74 percent of patients achieve absence of MASH with no worsening of scarring in a mid-stage trial. Accelerated approvals allow the FDA to move therapies that target serious and life-threatening conditions to the market more quickly. However, such approvals have been criticized because some drugs have later been proven to be ineffective.
Globe and Mail
a day ago
- Health
- Globe and Mail
Novo Nordisk's Wegovy gets accelerated U.S. approval for liver disease
Novo Nordisk said on Friday the U.S. Food and Drug Administration had granted accelerated approval for its weight-loss drug Wegovy to treat a serious liver condition known as metabolic dysfunction-associated steatohepatitis. The decision makes Wegovy the first GLP-1 class therapy cleared for MASH, a progressive liver condition that affects around 5% of adults in the U.S., according to the American Liver Foundation. The approval is for use alongside a reduced-calorie diet and increased physical activity. The FDA's approval was based on part one of a two-part study that showed Wegovy helped more patients with MASH and liver scarring improve the organ's condition, compared to a placebo. At 72 weeks, nearly 37% of patients on Wegovy saw an improvement in liver fibrosis, compared to 22.4% on placebo. Nearly 63% of those on Wegovy had their liver inflammation resolved, versus 34.3% for placebo. No worsening of the disease was seen in these patients. Accelerated approvals allow the agency to move therapies that target serious and life-threatening conditions to the market more quickly. However, such approvals have been criticized because some drugs have later been proven to be ineffective.
Reuters
a day ago
- Health
- Reuters
Novo Nordisk's Wegovy gets accelerated US approval for liver disease MASH
Aug 15 (Reuters) - Novo Nordisk ( opens new tab said on Friday the U.S. Food and Drug Administration had granted accelerated approval for its weight-loss drug Wegovy to treat a serious liver condition known as metabolic dysfunction-associated steatohepatitis. The decision makes Wegovy the first GLP-1 class therapy cleared for MASH, a progressive liver condition that affects around 5% of adults in the U.S., according to the American Liver Foundation. The approval is for use alongside a reduced-calorie diet and increased physical activity. The FDA's approval was based on part 1 of a two-part study that showed Wegovy helped more patients with MASH and liver scarring improve the organ's condition, compared to a placebo. At 72 weeks, nearly 37% of patients on Wegovy saw an improvement in liver fibrosis, compared to 22.4% on placebo. Nearly 63% of those on Wegovy had their liver inflammation resolved, versus 34.3% for placebo. No worsening of the disease was seen in these patients. Accelerated approvals allow the agency to move therapies that target serious and life-threatening conditions to the market more quickly. However, such approvals have been criticized because some drugs have later been proven to be ineffective.
Hindustan Times
20-06-2025
- Health
- Hindustan Times
Gastroenterologist shares top 3 symptoms of fatty liver: ‘Fatigue is probably one of the most commonly reported signs'
Fatty Liver disease occurs when there is a build-up of extra fat in liver cells. When it is not caused by alcohol, it is called nonalcoholic fatty liver disease, also known as NAFLD. Per the American Liver Foundation, it is normal for the liver to contain some fat – however, if it is more than 5-10 percent of the liver's weight, then it is alarming and can be called a fatty liver (steatosis). Also Read | Gastroenterologist reveals 4 best oils for deep frying so you can enjoy crispy pakoras this monsoon: Ghee to avocado oil Therefore, it becomes necessary to watch out for the signs that you may have a fatty liver. Dr Joseph Salhab, a gastroenterologist and 'expert in digestion, liver, pancreas and nutrition', in a video shared on Instagram on June 19, listed the top 3 symptoms one should look out for to know they have fatty liver or not. Explaining the three symptoms in his video, Dr Salhab said, 'Three symptoms of a fatty liver that you should know, with the last one being the most common symptom.' A post shared by Dr. Joseph Salhab (@thestomachdoc) Per the gastroenterologist, the first sign of a fatty liver is fatigue. He pointed out that it is probably one of the most commonly reported symptoms in people with a fatty liver. 'We think it's related to metabolic dysfunction of the liver and sleep disturbances that can occur in fatty liver disease,' he explained. Per Dr Salhab, another symptom of fatty liver is pain in the right upper quadrant of your belly. 'This can happen at random times during the day or after you eat, and sometimes it can indicate active inflammation of the liver,' he explained. According to the gastroenterologist, the number one and most common symptom of a fatty liver is absolutely nothing. 'In fact, most people with fatty liver have no signs and no symptoms. Fatty liver is a sneaky disease because 50 percent of people who have a fatty liver can even have normal lab tests,' he explained. The gastroenterologist further added, 'The reason why the top symptom is concerning is because it hides the fact that you have silent inflammation, and then if liver failure eventually occurs, you finally start showing symptoms.' Note to readers: This article is for informational purposes only and not a substitute for professional medical advice. Always seek the advice of your doctor with any questions about a medical condition.
Time of India
24-05-2025
- Health
- Time of India
5 signs your liver is not functioning well
Image credits: Getty Images The liver is one of the most important organs in the body. It performs hundreds of functions vital to sustain life and makes hormones and proteins that are required by other parts of the body. It cleans toxins, makes bile, regulates the amount of blood in the body and metabolizes proteins, carbohydrates and fats so the body can use them. But with the consumption of food high in saturated and trans fat, sugar, processed foods, dietary and medical supplements and alcohol, liver health can get damaged to the point of fatality. According to the American Liver Foundation, about 51,642 adults died from liver disease in 2020 in the United States. Are there any signs of depleting liver health? If yes, what are they? Find out below! Jaundice Image credits: Getty Images Liver damage can cause yellowing of the skin and eyes. This is because the liver is responsible for processing bilirubin, a yellow pigment produced from red blood cells and excreting it into bile. But when the liver is not functioning properly, it is not able to process the pigment which gets build up and leads to yellowing of skin and eyes. Abdominal pain and swelling Image credits: Getty Images If the upper right part of your abdomen pains frequently, it could be because of a damaged liver. Liver damage can cause inflammation and fluid build up in the abdomen which can cause sharp pain when you move and breathe. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Tukarkan Bitcoin dan Ethereum - Tanpa Dompet Diperlukan! IC Markets MULAI SEKARANG Undo Dark urine and pale stools Image credits: Getty Images Another easy-to-spot sign of liver damage is dark urine and pale stool. Due to the build-up of bilirubin in the liver, the urine may be excreted in darker colours than usual such as brown, orange or amber. Additionally, when the liver stops functioning properly it stops producing enough bile salts in the stool leading to a pale or clay colour or at times even disrupting the flow. Fatigue and weakness Image credits: Getty Images An unwell liver is weak at filtering out toxins from the bloodstream which can lead to you feeling more fatigue than usual and feeling unwell. It can also cause brain fog where you are confused or disoriented. And, due to fluid retention, you can feel weakness in your body and experience swelling in the feet and ankles. Bruising and bleeding Image credits: Getty Images When liver damage occurs, the organ doesn't produce enough clotting factors which are proteins required to clot blood and stop bleeding. This results in the body bruising and bleeding more rapidly. In the later stages, you can also end up vomiting blood due to the liver being clogged. One step to a healthier you—join Times Health+ Yoga and feel the change
