The Food and Drug Administration has approved the first medicine for a common liver disease that’s been a top target of drugmakers over the last decade.
The drug, known as Rezdiffra and developed by biotechnology company Madrigal Pharmaceuticals, was given an accelerated clearance on Thursday for use in adults with metabolic dysfunction-associated steatohepatitis, or MASH. The approval is specifically for people with the disease and moderate to advanced liver fibrosis, alongside diet and exercise. It’ll only be upheld if the drug’s benefits are confirmed in an ongoing trial.
In testing, treatment with Rezdiffra resolved MASH and helped improve the liver scarring that is typically associated with the condition.
“Previously, patients with [MASH] who also have notable liver scarring did not have a medication that could directly address their liver damage,” said Nikolay Nikolov, the acting director of the FDA office that evaluates immunology and inflammation drugs. “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise.”
The therapy’s labeling includes a safety warning for physicians to monitor for the elevation of liver enzymes or the development of liver-related side effects. The agency also recommends limiting use in cholesterol-lowering statins in people receiving Rezdiffra. The prescribing information doesn’t, however, require patients to undergo a liver biopsy before treatment, something that’s been seen as a potential barrier to use.
The approval is a turning point against a disease that, by one estimate, affects anywhere from 6 million to 8 million people. Previously known as NASH, the condition often develops alongside metabolic diseases like diabetes and obesity. It’s characterized by an accumulation of fat in the liver, causing progressive inflammation and scarring. In recent years, MASH has become one of the leading causes of liver transplants.
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