FDA Clears Novo Nordisk’s Wegovy for MASH Treatment | iPharmaCenter

August 15, 2025 – Bagsværd, Denmark – Novo Nordisk has received U.S. Food and Drug Administration (FDA) approval for an expanded use of its obesity drug Wegovy (semaglutide 2.4 mg). The new indication covers treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stages F2–F3), alongside diet and exercise.

The approval was granted under the FDA’s accelerated pathway and is supported by data from the Phase 3 ESSENCE trial. In part one of the study, Wegovy significantly outperformed placebo in improving liver health.

After 72 weeks, 36.8% of patients receiving Wegovy showed improved liver fibrosis without worsening steatohepatitis, compared with 22.4% on placebo. Additionally, 62.9% of patients on Wegovy achieved resolution of steatohepatitis without worsening fibrosis, compared with 34.3% of those on placebo.

The ESSENCE trial is a large, two-part global study designed to assess semaglutide’s potential in treating MASH with liver fibrosis. The first phase focused on liver histology improvements, while the second phase—running through 2029—will evaluate whether the drug can reduce the risk of serious liver-related complications over a longer timeframe.

Following the U.S. approval, Novo Nordisk has already submitted regulatory applications in the European Union (February 2025) and Japan (May 2025).