Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved an additional indication for Wegovy (semaglutide 2.4 mg) 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.

The accelerated approval is supported by results from part 1 of the ESSENCE trial, in which Wegovy demonstrated statistically significant and superior outcomes compared to placebo. Data showed meaningful improvement in liver fibrosis with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis.

At week 72, 36.8% of patients treated with Wegovy achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.4% in the placebo group. Additionally, 62.9% of patients on Wegovy achieved resolution of steatohepatitis with no worsening of liver fibrosis, versus 34.3% in the placebo group.

“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.

“MASH represents a significant health burden, with one in three people with overweight or obesity worldwide affected. In the US alone, around 22 million people are estimated to live with MASH. With the approval of Wegovy for MASH, we provide a new treatment to people living with MASH that not only halts the disease activity but helps reverse the damage caused to the liver.”

As of today, Wegovy is available in the US for the treatment of MASH.