Novo Nordisk’s Wegovy® Approved in the US for Treatment of MASH
Saturday, August 16, 2025
Novo Nordisk has received approval from the US Food and Drug Administration (FDA) for an additional use of Wegovy® (semaglutide 2.4 mg) to treat metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (stages F2 to F3).
MASH is a progressive liver disease linked to metabolic dysfunction, which can lead to advanced liver damage and increase the risk of liver cancer. It affects more than 250 million people worldwide, with prevalence expected to rise sharply by 2030. Many individuals with overweight or obesity also live with MASH, often without clear symptoms in the early stages, which contributes to late diagnosis.
The treatment is to be used alongside a reduced-calorie diet and increased physical activity.
The approval was granted through the FDA’s accelerated pathway based on results from part one of the phase 3 ESSENCE trial. The trial showed that Wegovy® significantly improved liver fibrosis without worsening steatohepatitis and promoted resolution of steatohepatitis without worsening fibrosis when compared to placebo.
At week 72, 36.8% of patients treated with Wegovy® achieved improvement in liver fibrosis with no worsening of steatohepatitis, compared to 22.4% in the placebo group. In addition, 62.9% of patients receiving Wegovy® achieved resolution of steatohepatitis with no worsening of fibrosis, compared to 34.3% of those on placebo.
With this decision, Wegovy® becomes the first GLP-1 therapy approved for the treatment of MASH in the US. The therapy is already available for weight management and for reducing the risk of major cardiovascular events in people with obesity or overweight and related health conditions.
Source: novonordisk.com
