Wegovy injection pens arranged in Waterbury, Vermont, US, on Monday, April 28, 2025.
Shelby Knowles | Bloomberg | Getty Images
Shares of Novo Nordisk climbed almost 5% Monday after the company’s blockbuster Wegovy obesity drug received accelerated approval from the U.S. Food and Drug Administration to treat a serious liver disease.
The company on Friday said that it was granted approval for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis, in combination with a reduced calorie diet and increased physical activity.
Novo Nordisk shares were up 5.46% by 10:43 a.m. London time (5:43 a.m. E.T.).
The approval makes Wegovy the first GLP-1 class treatment to be authorized for MASH, a progressive liver condition that affects an estimated 5% of U.S. adults, according to the American Liver Foundation.
It also advances the drug’s applications beyond diabetes and obesity treatment and develops its presence in the metabolic disease market. The approval follows a series of studies indicating the drug’s efficacy in reducing the risk of heart attack, stroke and death from cardiovascular causes.
“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,” Martin Holst Lange, Novo Nordisk executive vice president, chief scientific officer and head of research and development, said in a statement.
The accelerated approval was based on the first phase of the ESSENCE trial, in which Novo Nordisk said Wegovy demonstrated “a statistically significant and superior improvement” in liver fibrosis compared to placebo.
Under the study, the company said almost two-thirds (62.9%) of people treated with Wegovy achieved the resolution of steatohepatitis with no worsening of liver fibrosis, compared to 34.3% who were administered a placebo.
More than one-third (36.8%) of those treated with Wegovy achieved improvement in liver fibrosis with no worsening of steatohepatitis after 72 weeks, compared to 22.4% who received a placebo. The second phase of the study is expected in 2029.
Novo Nordisk said Friday that Wegovy would be immediately available in the U.S. for MASH. The only other MASH treatment currently approved by the FDA is Madrigal Pharmaceuticals’ Rezdiffra, which was cleared in 2024.