Novo Nordisk gains liver disease approval for Wegovy

FDA grants accelerated approval for Wegovy to treat MASH in adults with liver fibrosis, sending Novo Nordisk shares higher and widening Wegovy’s potential use.

Novo Nordisk Stock Rises After Wegovy Approved for Liver Disease

Novo Nordisk shares rose after the U.S. FDA granted accelerated approval for Wegovy to treat metabolic-associated steatohepatitis in adults with moderate to advanced liver fibrosis. The decision makes Wegovy the first GLP-1 therapy cleared for MASH and follows the ESSENCE trial results showing fibrosis improvement in 37% of patients versus 22% on placebo, with more patients experiencing inflammation relief. Novo Nordisk said Wegovy will be available in the U.S. immediately and should be used alongside diet and exercise.

In the market, Novo Nordisk stock climbed about 7% in after-hours trading, rebounding from a recent drop after the company cut its 2025 sales outlook, shaving billions from its market value. Madrigal Pharmaceuticals fell more than 6% as investors treated Wegovy’s entry into MASH as a competitive threat, while Eli Lilly may face added pressure as its own GLP-1 program advances. Analysts estimate a potential $30 billion market for Wegovy beyond obesity and heart disease, if payer coverage and pricing cooperate. Novo has filed for Wegovy in Europe and Japan, with Part 2 ESSENCE results due in 2029, and is pursuing broader insurer access even as pricing details remain undisclosed.

The FDA approval signals a shift in how drugmakers pursue GLP-1 therapies, extending Wegovy beyond weight loss into liver care and possibly reshaping price discussions with insurers. This move heightens competition in the GLP-1 space, inviting rivals to accelerate plans or seek new indications of their own. In the near term, investors will watch for how price, reimbursement, and real-world uptake unfold, as the pathway from clinical success to steady revenue is never guaranteed.

Longer term, the success of this strategy hinges on broader evidence from Part 2 of ESSENCE and the willingness of payers to cover Wegovy for liver disease. Regulatory hurdles in Europe and Japan, plus the complexity of liver disease treatment economics, will influence how quickly Wegovy reaches a broad patient base. Novo Nordisk’s effort to diversify Wegovy’s use reflects a broader industry trend: turning a blockbuster obesity drug into a platform medicine.

Highlights

As Wegovy moves into new medical territory, the real test will be affordability and access for patients.