Approval of First Drug for Liver Disease Affecting Millions

U.S. health authorities approved, on Thursday, the first treatment for the acute form of human fatty liver disease, which affects millions of people in the United States. This treatment, developed by Madrigal Pharmaceuticals, is now permitted for adults suffering from non-alcoholic steatohepatitis (NASH) who also have liver fibrosis. Non-alcoholic steatohepatitis is characterized by an abnormal accumulation of fat in the liver, leading to chronic inflammation of this organ. Its cells gradually get replaced with fibrosis, which is scar tissue that can develop into liver cirrhosis or even cancer. This disease is closely associated with obesity, representing a huge market for pharmaceutical companies. The American Liver Foundation stated in a statement that the decision by the U.S. Food and Drug Administration (FDA) "brings hope to millions of Americans." The foundation predicts that non-alcoholic fatty liver disease is expected to become the leading cause of liver transplants in the United States by 2025. Approximately 6 to 8 million Americans are likely to be affected by this new treatment, a number expected to continue increasing, according to FDA estimates. Nikolai Nikolov, an official at the FDA, stated in a statement that these patients "previously had no medication that could directly impact the liver damage." The treatment is taken orally once a day, alongside a healthy diet and exercise. The approval was based on a clinical trial involving about 900 participants, which showed benefits for those receiving the treatment after 12 months, compared to others who received a placebo. The most common side effects reported were diarrhea and nausea. Bill Sebold, director of Madrigal Pharmaceuticals, stated in a statement that this approval "culminates 15 years of research," adding that "it is a historic moment" in this field. The company noted that the treatment will be available to patients in the United States starting in April through specialized pharmacies.