FDA Approves Rezdiffra (Resmetirom) for Fatty Liver Disease NASH (Also Known as MASH)


The U.S. Food and Drug Administration (FDA) has approved the first medicine to treat a common liver disease known as nonalcoholic steatohepatitis, also called fatty liver disease.

Regulators have cleared the new daily pill, Rezdiffra (resmetirom), for adults with NASH — noncirrhotic nonalcoholic steatohepatitis — with moderate to advanced liver scarring (fibrosis). The medication should be used along with diet and exercise, the agency said in a statement.

NASH — also known as metabolic dysfunction–associated steatohepatitis (MASH) — is caused by a buildup of fat in the liver that typically occurs when people are overweight or have obesity.

NASH is an advanced form of nonalcoholic fatty liver disease (NAFLD). This condition develops when fat accumulates in the liver, causing inflammation and tissue damage over time that can lead to fibrosis. It can progress to cirrhosis, or very advanced disease that may only be treated with a liver transplant.

“Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Nikolay Nikolov, MD, acting director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research, in the statement. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”


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