The US has become the first country to approve semaglutide for liver disease, with its Food and Drug Administration giving the go-ahead for Novo Nordisk’s Wegovy to be used for metabolic dysfunction-associated fatty liver disease.

The drug was approved this month to treat non-cirrhotic metabolic dysfunction–associated fatty liver disease (MAFLD) — known in the US as metabolic dysfunction–associated steatohepatitis (MASH) — in adults with moderate to advanced liver fibrosis, in combination with a reduced-calorie diet and increased physical activity.

An application for use of the drug to treat MAFLD in Australia is currently before the TGA.

The FDA decision comes after Novo Nordisk released interim phase III clinical trial results in April, which showed that 63% of 534 patients on semaglutide had resolution of MAFLD without worsening of fibrosis, compared with 34% of 266 patients on placebo, after 72 weeks.