FDA Grants Accelerated Approval to Wegovy for the Treatment of Liver Disease MASH

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Wegovy—Novo Nordisk’s weight-loss medication—for the treatment of the serious liver disease metabolic dysfunction-associated steatohepatitis (MASH). This makes Wegovy the first GLP-1 class therapy authorized for this condition, according to Reuters.

According to the American Liver Foundation, MASH affects approximately 5% of the adult population in the U.S. Until now, treatment options have been limited. The only previously approved therapy was Madrigal Pharmaceuticals’ Rezdiffra, launched in 2024.

Novo Nordisk announced that Wegovy is now available for adult patients with MASH and moderate to advanced liver fibrosis. The medication is recommended for use alongside a healthy diet and physical activity.

“Patients with MASH need timely access to therapies that can prevent disease progression,” Dr. Jason Brett, Executive Director of Medical Affairs at Novo Nordisk US, told Reuters. The company is working with insurers to ensure broader coverage and access, though it has not disclosed specific pricing parameters.

The approval is based on results from the first part of a two-phase clinical trial. These results showed improvement in liver condition in patients on Wegovy compared to those on a placebo. The second part of the study is expected to conclude in 2029.

Competitor Eli Lilly is also testing its medication tirzepatide (the active ingredient in Mounjaro and Zepbound), which in a mid-stage trial led to the resolution of MASH in up to 74% of patients without worsening fibrosis.