FDA Grants Wegovy 3rd Indication: First GLP-1 Approved for MASH with Moderate-to-Advanced Liver Scarring

The FDA has granted accelerated approval for Novo Nordisk’s Wegovy (semaglutide 2.4 mg) as the first GLP-1 receptor agonist to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis (stages F2 to F3), alongside diet and exercise.1345

Approval is based on Phase 3 results from the ESSENCE trial, which showed Wegovy significantly improved liver fibrosis without worsening steatohepatitis and achieved resolution of steatohepatitis without worsening fibrosis compared to placebo.345

At week 72 in ESSENCE, 36.8% of Wegovy-treated patients had fibrosis improvement without worsening steatohepatitis versus 22.4% on placebo; 62.9% had resolution of steatohepatitis without fibrosis worsening compared to 34.3% on placebo.34

Wegovy becomes available in the US for MASH as of August 2025, joining Madrigal Pharmaceuticals’ Rezdiffra as the only specifically approved treatments for this condition.145

Full approval for this indication is contingent on long-term data from the ongoing ESSENCE trial, with final results expected in 2029.45

Wegovy is not approved for patients with cirrhosis, only for those with moderate-to-advanced fibrosis due to MASH.5

Sources:

1. https://www.biopharmadive.com/news/novo-wegovy-mash-fda-approval-rezdiffra-madrigal/757853/

3. https://www.biospace.com/press-releases/novo-nordisk-a-s-wegovy-approved-in-the-us-for-the-treatment-of-mash

4. https://www.pharmaceutical-technology.com/news/wegovy-glp-1ra-fda-mash-approval/

5. https://www.ajmc.com/view/fda-approves-semaglutide-for-mash-with-fibrosis