Novo Nordisk Announces FDA Approval of Wegovy® as First GLP-1 Therapy for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

On August 19, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) had recently approved a new indication for Wegovy® (known as NovoGain® in China, semaglutide 2.4 mg) based on a supplemental New Drug Application (sNDA): to be used in conjunction with diet control and increased physical activity for the treatment of non-cirrhotic adult patients with metabolic dysfunction-associated steatohepatitis (MASH) accompanied by moderate to severe liver fibrosis (corresponding to F2-F3 stage fibrosis). Martin Holst Lange, Executive Vice President and Chief Scientific Officer (CSO) of Novo Nordisk’s Research & Development, stated: “Wegovy® now holds a unique position: it is the first and only GLP-1 drug approved for the treatment of MASH.”