15 August 2025 - Novo Nordisk today announced that the US FDA has approved an additional indication for Wegovy (semaglutide 2.4 mg) based on a supplemental new drug application for treatment of non-cirrhotic 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.

Read Novo Nordisk press release