MASH win for Novo Nordisk’s Wegovy
Denmark’s Novo Nordisk (NOV: N) scored a significant regulatory win for GLP-1 drug Wegovy (semaglutide), as the US Food and Drug Administration (FDA) has approved an additional indication for the drug. The firm's shares rose 4% to 338.85 kroner in early trading on Monday, following the late Friday announcement.
The FDA authorized Wegovy for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in combination with a reduced calorie diet and increased physical activity. As of Friday, Wegovy is available in the USA for the treatment for MASH, Novo Nordisk stated.
The success of semaglutide, also marketed as Ozempic for the treatment of type 2 diabetes, has driven Novo Nordisk to be the biggest drugmaker in Europe and among the top few worldwide. First-half 2025 sales of Ozempic came in at 66.59 billion kroner ($10.45 billion), while those of Wegovy were 36.89 billion kroner.
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