Wegovy injection pens organized in Waterbury, Vermont, US, on Monday, April 28, 2025.
Shelby Knowles | Bloomberg | Getty Photos
Shares of Novo Nordisk climbed nearly 5% Monday after the corporate’s blockbuster Wegovy weight problems drug obtained accelerated approval from the U.S. Meals and Drug Administration to deal with a severe liver illness.
The corporate on Friday mentioned that it was granted approval for the remedy of metabolic dysfunction-associated steatohepatitis (MASH) in adults with reasonable to superior liver fibrosis, together with a diminished calorie food regimen and elevated bodily exercise.
Novo Nordisk shares have been up 5.46% by 10:43 a.m. London time (5:43 a.m. E.T.).
The approval makes Wegovy the primary GLP-1 class remedy to be approved for MASH, a progressive liver situation that impacts an estimated 5% of U.S. adults, in line with the American Liver Basis.
It additionally advances the drug’s functions past diabetes and weight problems remedy and develops its presence within the metabolic illness market. The approval follows a collection of research indicating the drug’s efficacy in lowering the danger of coronary heart assault, stroke and loss of life from cardiovascular causes.
“Wegovy is now uniquely positioned as the primary and solely GLP-1 remedy accepted for MASH, complementing the already confirmed weight reduction, cardiovascular advantages and intensive physique of proof linked to semaglutide,” Martin Holst Lange, Novo Nordisk government vp, chief scientific officer and head of analysis and improvement, mentioned in a press release.
The accelerated approval was based mostly on the primary part of the ESSENCE trial, wherein Novo Nordisk mentioned Wegovy demonstrated “a statistically vital and superior enchancment” in liver fibrosis in comparison with placebo.
Underneath the examine, the corporate mentioned nearly two-thirds (62.9%) of individuals handled with Wegovy achieved the decision of steatohepatitis with no worsening of liver fibrosis, in comparison with 34.3% who have been administered a placebo.
A couple of-third (36.8%) of these handled with Wegovy achieved enchancment in liver fibrosis with no worsening of steatohepatitis after 72 weeks, in comparison with 22.4% who obtained a placebo. The second part of the examine is anticipated in 2029.
Novo Nordisk mentioned Friday that Wegovy can be instantly accessible within the U.S. for MASH. The one different MASH remedy presently approved by the FDA is Madrigal Prescribed drugs’ Rezdiffra, which was cleared in 2024.
