Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday. The condition is called non-cirrhotic non-alcoholic steatohepatitis (NASH). NASH with liver scarring is thought to affect up to 8 million Americans. It’s often tied to high blood pressure and type 2 diabetes, the FDA explained in a statement. “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Dr. Nikolay Nikolov, acting director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise,” Nokolov said in the FDA statement. The liver is a vital organ that cleanses the blood and helps with digestion by secreting bile. However, over time, inflammation caused by obesity, diabetes and high blood pressure can cause nonalcoholic liver disease, which triggers fat accumulation in the liver, liver scarring and dysfunction. As the FDA explained, “Rezdiffra is a partial activator of a thyroid hormone receptor; activation of this receptor by Rezdiffra in the liver reduces liver fat accumulation.” The agency said that the drug was approved under an “accelerated”… read on > read on >

















