Wegovy Gets Approval for MASH
The U.S. Food and Drug Administration (FDA) has accelerated approval for Novo Nordisk’s Wegovy for MASH (metabolic dysfunction-associated steatohepatitis.
Correspondingly, the move officially makes Wegovy the first GLP-1 medication to treat the progressive liver disease. Currently, around 5% of U.S. adults suffer from MASH, according to the American Liver Foundation.
As a result, Novo Nordisk further cements its position beyond the obesity and metabolic disease treatment landscape.
Background: MASH and Wegovy
MASH, previously known as NASH, is a severe form of fatty liver disease linked to obesity, diabetes, and metabolic dysfunction. In particular, the condition causes inflammation and fibrosis that can progress to cirrhosis and liver failure.
Until recently, Madrigal’s Rezdiffra was the only option with FDA approval for patients. Now, Wegovy expands treatment choices while positioning Novo Nordisk as a frontrunner in liver disease therapies.
“There really (have) not been good treatments in this space,” remarked Jason Brett, U.S. principal head at Novo Nordisk, speaking to Reuters.
“We’re only the second FDA-approved treatment for MASH, and we really need better medications that have better overall benefit-risk profiles, that really can also prevent the progression of the disease,” he added.
Clinical Trial Evidence
The FDA decision for MASH relied on interim data from the ESSENCE Phase III trial. In the trial, about 800 patients received semaglutide or placebo for 72 weeks.
Results showed that 37% of Wegovy patients improved liver fibrosis without worsening steatohepatitis, compared with 22.5% on placebo.
Moreover, 62.9% achieved resolution of steatohepatitis without worsening fibrosis, versus 34.1% in the placebo group. These numbers underline Wegovy’s clear clinical impact on liver health outcomes.
Reaction to Approval for Mash
Unsurprisingly, Novo Nordisk’s shares rose between 4% and 5.7% immediately after the announcement. Overall, investors welcomed the expansion of Wegovy’s label, especially since it followed earlier market value declines in 2025.
Additionally, analysts believe the approval provides a short-term advantage over rival Eli Lilly, which is developing tirzepatide for MASH. However, competition remains fierce in the fast-growing GLP-1 space.
Strategic Implications
The approval for MASH broadens Wegovy’s use beyond weight management and cardiovascular risk reduction, further integrating it into metabolic disease treatment strategies.
Consequently, Novo Nordisk gains an edge in diversifying its revenue streams. Yet, the company faces mounting pressure from generic challengers and telehealth pharmacies that compound GLP-1 medications.
Furthermore, Part 2 of the ESSENCE trial will not conclude until 2029, leaving long-term benefits under review.
Quotes and Commentary
Notably, Novo Nordisk has stressed the importance of treating MASH early.
Analysts echoed this sentiment, noting that the accelerated approval could restore investor confidence. They also cautioned that Lilly’s upcoming readouts may quickly change competitive dynamics.
Conclusion
In summary, Wegovy’s accelerated approval marks a milestone for Novo Nordisk and for patients with limited treatment options. Moreover, the decision provides new hope for millions at risk of liver complications and reinforces Novo Nordisk’s leadership in metabolic disease care.
At the same time, success in MASH will depend on execution, market access, and how quickly competitors catch up.
Photo: Freepik
