Novo Nordisk's Wegovy Snags Conditional FDA Nod For Fatty Liver Disease

On Saturday, the U.S. Food and Drug Administration (FDA) approved an additional indication for Novo Nordisk A/S’ (NYSE:NVO) Wegovy (semaglutide 2.4 mg) based on a supplemental New Drug Application (sNDA) for 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.

The accelerated approval is based on part 1 of the ESSENCE trial, in which Wegovy demonstrated a statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis compared to placebo.

The clinical data from ESSENCE showed that at week 72, 36.8% of people treated with Wegovy achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.4% treated with placebo. 62.9% of people treated with Wegovy achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.3% treated with placebo.

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