Wegovy (semaglutide 2.4 mg) approved in the US for the treatment of MASH – Novo Nordisk
Novo Nordisk announced that the 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, 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.
“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 for MASH.
About the ESSENCE trial
ESSENCE is a phase III 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). ESSENCE is a two-part trial where 1,200 planned participants were randomised 2:1 to receive semaglutide 2.4 mg or placebo, on top of standard of care for 240 weeks. In part 1, the objective was to demonstrate that treatment with semaglutide 2.4 mg improves liver histology at 72 weeks based on biopsy sampling from the first 800 randomised patients. In part 2, the objective is to demonstrate that treatment with semaglutide 2.4 mg lowers the risk of liver-related clinical events compared to placebo in adults with MASH and moderate to advanced liver fibrosis at 240 weeks.
Based on part 1 of the ESSENCE trial, Novo Nordisk has also filed for regulatory approval in the EU in February 2025, with a subsequent filing in Japan in May 2025. Part 2 of the ESSENCE trial is expected to read out in 2029.
