FDA Approves Wegovy® (Semaglutide) for Treatment of MASH with Liver Fibrosis

The US FDA has granted accelerated approval to Novo Nordisk’s Wegovy® (semaglutide 2.4 mg) for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (F2–F3). The approval, based on the ESSENCE trial, allows Wegovy® to be used alongside reduced-calorie diet and increased physical activity.

In the study, Wegovy® significantly improved outcomes compared to placebo. At 72 weeks, 36.8% of patients achieved improvement in liver fibrosis without worsening steatohepatitis (vs. 22.4% with placebo). Additionally, 62.9% achieved resolution of steatohepatitis with no worsening of fibrosis (vs. 34.3% with placebo).

With this approval, Wegovy® becomes the first GLP-1 therapy authorized for MASH, adding to its established benefits in weight loss and cardiovascular health. MASH affects nearly 22 million people in the US, representing a major health challenge linked to obesity.