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Nash

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health1 year ago

"FDA Approves Madrigal Pharmaceuticals' Rezdiffra as First Treatment for Common NASH Liver Disease"

The FDA has approved the first medication, Rezdiffra, for nonalcoholic steatohepatitis (NASH), a common form of liver inflammation associated with obesity and metabolic conditions. The medication, developed by Madrigal Pharmaceuticals, showed promising results in reducing fat accumulation in the liver and achieving NASH resolution with no worsening of fibrosis in clinical trials. It is intended to be used alongside a healthy diet and exercise and is expected to be available next month. The approval marks a significant milestone in NASH treatment and offers hope for patients and healthcare providers.

via CNN|
#fda#health#liver-inflammation
health1 year ago

"FDA Greenlights First-Ever Drug for Fatty Liver Disease NASH"

The FDA has approved Rezdiffra (resmetirom) as the first treatment for adults with noncirrhotic non-alcoholic steatohepatitis (NASH) and moderate to advanced liver scarring, to be used alongside diet and exercise. NASH, a result of nonalcoholic fatty liver disease, can lead to liver scarring and dysfunction. Rezdiffra, a partial activator of a thyroid hormone receptor, showed promising results in reducing liver fat accumulation in a 54-month trial. Common side effects include diarrhea and nausea, and precautions include drug-induced liver toxicity and gallbladder-related side effects. The approval was granted under the accelerated approval pathway, and a postapproval study is ongoing to assess clinical benefit after 54 months of treatment.

via FDA.gov|
#fda#health#liver-scarring
health1 year ago

"Matrix Viscoelasticity and Liver Cancer Progression"

The accumulation of advanced glycation end products (AGEs) in the extracellular matrix (ECM) of the liver leads to increased viscoelasticity, creating a tumorigenic environment that promotes the progression of hepatocellular carcinoma (HCC). Studies in human and mouse liver samples, as well as 3D hydrogel models, demonstrate that AGEs modulate collagen architecture and network connectivity, resulting in enhanced viscoelasticity. This increased viscoelasticity activates the YAP mechanotransductive pathway, promoting tumour growth and invasion. Inhibiting AGE production or disrupting AGE–collagen cross-links reverses the changes in viscoelasticity and reduces tumour growth, highlighting the potential for targeting ECM viscoelasticity in the treatment of liver cancer.

via Nature.com|
#ages#health#liver-cancer
health2 years ago

Sagimet's Denifanstat Shows Promise in Treating Fatty Liver Disease

Sagimet Biosciences announces positive topline results from its Phase 2b FASCINATE-2 clinical trial of denifanstat, a fatty acid synthase inhibitor, in NASH patients with stage 2 or 3 fibrosis. The trial showed statistically significant improvements in NASH resolution, fibrosis reduction, and liver health markers compared to placebo. Denifanstat was generally well-tolerated, with no treatment-related serious adverse events observed. The company plans to advance to Phase 3 development and aims to start in the second half of 2024.

via GlobeNewswire|
#clinical-trial#denifanstat#fatty-acid-synthase-inhibitor
healthcare2 years ago

Akero's NASH Treatment Fails, Stock Plummets

Shares of Akero Therapeutics (AKRO) and 89bio (ETNB) plummeted after Akero's liver-disease treatment failed to meet expectations in a midstage study. While the drug showed statistically significant results in resolving NASH, the improvement in liver scarring was not statistically significant. Despite this, analysts believe that the effectiveness data sets for both companies are strong, with 89bio potentially pulling ahead due to its dosing schedule and lower side effects. Akero shares fell 64% and 89bio shares tumbled 36.6% as a result of the news.

via Investor's Business Daily|
#89bio#akero-therapeutics#healthcare
health2 years ago

"Name Changes in Liver Disease Community Spark Confusion: NASH vs MASH?"

The liver disease community is facing confusion as a global group of liver disease societies voted to change the name of NASH (nonalcoholic steatohepatitis) to MASH (metabolic dysfunction-associated steatohepatitis). However, the new names have gained little traction, with health information sources like WebMD and MayoClinic.org not updating their directories with the new nomenclature. Organizations with NASH in their titles have also not mentioned any upcoming changes, leading to uncertainty in the community.

via Endpoints News|
#confusion#health#liver-disease
health2 years ago

Promising Breakthrough: New Treatment Discovered for Liver Disease and NASH-related Fibrosis

A clinical trial led by researchers at the University of California San Diego School of Medicine has identified a potential new treatment for non-alcoholic steatohepatitis (NASH)-related fibrosis. The trial found that a drug called pegozafermin, which mimics a hormone in the body, improved liver fibrosis and inflammation in patients with NASH. Currently, there are no FDA-approved therapies for NASH, a condition that can lead to cirrhosis and other complications. The drug showed promising results in improving liver fibrosis, inflammation, and other biomarkers associated with NASH activity. Further research is needed to assess the drug's safety and efficacy in larger trials.

via Medical Xpress|
#clinical-trial#fibrosis#health
health2 years ago

Negotiating Treatment for Fatty Liver Patients

Weight loss is the most effective treatment for non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), according to a review in the journal Diabetes, Obesity and Metabolism. Losing at least 5% of body weight can reduce the effects of diabetes and obesity, while a 10% reduction reduces the chance of progression from NAFLD to NASH or from NASH to early fibrosis. Eating more whole and fewer processed foods, exercising more, employing a GLP-1 agonist, or advising bariatric surgery for appropriate patients are all options for weight loss. Primary care clinicians can use the FIB-4 assessment to determine patients most at risk for NASH and eventually cirrhosis.

via Medscape|
#health#liver-disease#nafld
health2 years ago

Understanding Fatty Liver: Causes, Symptoms, and Treatment Options

Fatty liver disease, also known as nonalcoholic steatohepatitis (NASH), is a silent disease that rarely presents with symptoms until it is severe. It is projected to be the number one cause of liver transplantation in the US by 2030 and is rising in children. The number one risk factor for fatty liver disease is Type 2 diabetes, and metabolic syndrome encapsulates most of the risks for its development. Patients with two or more metabolic risk factors, elevated liver enzymes, or hepatic fat seen on ultrasound or CT scan should undergo screening. Fatty liver disease is reversible, and the most important treatment is lifestyle modifications like diet and exercise, with the Mediterranean diet being the best option for cardiovascular health.

via USA TODAY|
#fattyliverdisease#health#metabolicsyndrome
crime2 years ago

Texas Teen Claims Family Were Cannibals Before Killing Them

An 18-year-old Texas teen, Cesar Olalde, has been charged with capital murder after allegedly shooting and killing his parents, sister, and brother. According to a probable cause affidavit, Olalde told a co-worker of his sister that he killed his family because "they were cannibals, and they were going to eat him." The bodies were found in the bathroom of their home in Nash, Texas, with multiple gunshot wounds. Olalde is being held on $10 million bond.

via NBC News|
#cannibalism#crime#family-murder
finance2 years ago

FDA to Review Intercept Pharmaceuticals' Obeticholic Acid for Pre-Cirrhotic Fibrosis in NASH.

Trading of Intercept Pharmaceuticals' common stock has been halted as the FDA's Gastrointestinal Drugs Advisory Committee reviews obeticholic acid as a treatment for pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 22, 2023, for the review of the New Drug Application (NDA) for obeticholic acid. Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases.

via Yahoo Finance|
#fda#finance#intercept-pharmaceuticals
healthcare2 years ago

Intercept's NASH treatment faces safety concerns and plunging shares.

The US FDA staff has raised concerns about the safety risks of Intercept Pharmaceuticals' treatment for nonalcoholic steatohepatitis (NASH), called obeticholic acid (OCA), citing increased risk of diabetes and liver injury. The FDA's outside advisers are set to discuss the drug on Friday. The drug was expected to become the first approved NASH therapy, but the FDA rejected the company's marketing application in 2020 due to potential risks. The total patient population eligible for OCA, if approved, will be between 6 million and 8 million Americans.

via Reuters|
#drug-safety#fda#healthcare
pharmaceuticals2 years ago

FDA Raises Concerns Over Intercept's NASH Treatment, Stock Drops.

The FDA has released briefing documents ahead of an advisory committee meeting stating that Intercept's Ocaliva cannot be justified for use in NASH subjects with Stage 2 or 3 fibrosis. This comes after the FDA rejected Intercept's push for accelerated approval in 2020. Meanwhile, X4 Pharmaceuticals has released more positive data from its Phase III study of mavorixafor as a treatment of WHIM syndrome, and PTC Therapeutics has claimed a Phase III win in rare genetic disease phenylketonuria. The FDA will also review Takeda's enzyme replacement therapy for an ultra-rare blood clotting disorder, and Canadian biotech enGene plans to combine with a Forbion-led blank check company to land a seat on Nasdaq and get to an FDA approval request in the first half of 2025.

via Endpoints News|
#drug-approval#fda#gene-therapy
biotech2 years ago

Viking Therapeutics Soars on Positive NASH Trial Results

Viking Therapeutics' liver disease treatment for nonalcoholic steatohepatitis (NASH) led to a significant reduction in liver fat and other lipid abnormalities in patients over 12 weeks compared to a placebo. The market for NASH treatments is expected to reach $24.3 billion by 2028. Viking's stock initially yo-yoed but hit a record high after the promising test results were unveiled, with shares trading near a record high and remaining well above their 50-day and 200-day moving averages.

via Investor's Business Daily|
#biotech#liver-disease#nash