FDA Approves Novo Nordisk’s Wegovy for MASH

Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved an additional indication for Wegovy (semaglutide 2.4 mg) based on a supplemental New Drug Application (sNDA) for 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.

The accelerated approval is based on part 1 of the ESSENCE trial. ESSENCE is a phase 3 trial evaluating the effect of once-weekly subcutaneous semaglutide 2.4 mg in adults with metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis (stage 2 or 3).

In the trial, 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.

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.

“Wegovy is now uniquely positioned as the first and only GLP-1 treatment approved for MASH, complementing the already proven weight loss, cardiovascular benefits, and extensive body of evidence linked to semaglutide,” said Martin Holst Lange, executive vice president, chief scientific officer, and head of Research and Development, at Novo Nordisk.