FDA Grants Accelerated Approval to Wegovy for MASH With Liver Fibrosis

The FDA granted accelerated approval on August 15, 2025 for Wegovy (semaglutide 2.4 mg) to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis, in combination with a reduced-calorie diet and increased physical activity. The decision made the injectable GLP-1 receptor agonist the first medicine in its class cleared for the liver condition, and it expanded the label of a peptide drug already approved for other uses.

MASH, previously referred to as nonalcoholic steatohepatitis (NASH), is a progressive form of fatty liver disease characterized by liver inflammation and scarring (fibrosis) that can advance toward cirrhosis. The new indication applies specifically to patients with moderate-to-advanced fibrosis, described as stages F2 to F3, and does not extend to patients who have already progressed to cirrhosis.

The approval was based on the Phase 3 ESSENCE trial. In the analysis supporting the decision, 63% of participants treated with semaglutide achieved resolution of steatohepatitis without worsening of fibrosis at 72 weeks, compared with 34% on placebo, and 37% achieved improvement in fibrosis without worsening of steatohepatitis, versus 22% on placebo. A third of treated participants met both endpoints, compared with 16% in the placebo group.

As an accelerated approval, the clearance was based on histologic surrogate endpoints considered reasonably likely to predict clinical benefit, with continued approval potentially contingent on confirmatory evidence. The ESSENCE trial included a longer second phase designed to assess whether the drug reduces liver-related clinical events over an extended follow-up period.

Semaglutide first reached the U.S. market for chronic weight management in 2021, with subsequent expansions including cardiovascular risk reduction in adults with established cardiovascular disease and obesity. The MASH decision added a distinct therapeutic indication and followed the 2024 approval of resmetirom, a separate, non-peptide drug that was the first therapy cleared specifically for the condition. This report describes the approved indication and trial findings and does not constitute medical or dosing guidance.