FDA Approves Semaglutide for Fatty Liver Disease Treatment in the United States
2025-08-19 / Read about 0 minute
Author:小编   

Novo Nordisk has announced that its drug Wegovy® (commercial name in China: Nuoheying®, semaglutide 2.4 mg) has received approval from the U.S. Food and Drug Administration (FDA) for a novel indication: the treatment of non-cirrhotic adult patients suffering from metabolic-associated fatty liver disease (MAFLD) with moderate-to-severe liver fibrosis (stages F2-F3). This expedited approval was grounded in Phase 1 data from the ESSENCE trial, demonstrating that Wegovy® significantly outperformed placebo in ameliorating liver fibrosis and steatohepatitis. Notably, at week 72, 36.8% of subjects administered Wegovy® achieved improvement in liver fibrosis without exacerbating steatohepatitis, compared to 22.4% in the placebo group. Furthermore, 62.9% of Wegovy®-treated subjects experienced improvement in steatohepatitis without worsening liver fibrosis, as opposed to 34.3% in the placebo group.