Novo Nordisk has received the US Food and Drug Administration’s (FDA) accelerated approval for Wegovy (semaglutide 2.4mg) to treat noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis.
The drug is approved for use alongside a reduced-calorie diet and increased physical activity.
Wegovy was initially approved in 2021 by the FDA to help adults with obesity or excess weight-related medical issues lose and maintain weight.
In 2022, its indication was expanded to include children aged 12 and older with obesity.
Last year, it was further approved to reduce the risk of major cardiovascular events in adults with heart disease and obesity or overweight.
Novo Nordisk executive vice president, chief scientific officer and research and development head Martin Holst Lange said: “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.
“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.”
The FDA approval of Wegovy for MASH treatment is based on Part 1 of the Phase 3 ESSENCE trial, which evaluated once-weekly subcutaneous semaglutide 2.4mg.
ESSENCE is a two-part trial with 1,200 participants randomised to receive either semaglutide 2.4mg or placebo over 240 weeks.
Part 1 clinical trial showed significant improvements in liver fibrosis and resolution of steatohepatitis without worsening liver conditions compared to placebo.
At week 72, 36.8% of Wegovy-treated patients showed improvement in liver fibrosis without worsening steatohepatitis, compared to 22.4% with placebo.
In addition, 62.9% of Wegovy-treated patients achieved resolution of steatohepatitis without worsening liver fibrosis, compared to 34.3% who were on placebo.
Based on the positive outcomes from part 1 of the trial, Novo Nordisk filed for regulatory approval in the European Union (EU) in February this year and Japan in May 2025.
