Novo Nordisk said Friday its popular weight-loss drug Wegovy has been approved by the U.S. Food and Drug Administration to treat a common type of liver disease, further expanding the blockbuster drug's market.
The new indication is for adults with metabolic dysfunction-associated steatohepatitis, or MASH, a serious condition linked to obesity that can lead to liver failure.
The accelerated approval covers patients with moderate to advanced liver scarring, known as fibrosis, but who do not have cirrhosis, the company said.
The decision was based on a late-stage trial where 36.8% of patients on Wegovy showed improvement in liver fibrosis without their underlying liver inflammation worsening, compared to 22.4% of those on a placebo.
This marks the latest expanded use for Wegovy, which was first cleared for weight management in 2021 and later to reduce cardiovascular risks in overweight or obese adults.
“Wegovy is now uniquely positioned as the first and only GLP-1 treatment approved for MASH, complementing the already proven weight loss, cardiovascular benefits and extensive body of evidence linked to semaglutide,” said Martin Holst Lange, head of Research and Development at Novo Nordisk.
The company estimates that around 22 million people in the U.S. live with MASH.
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