FDA Approves Wegovy for Adults with MASH, Liver Fibrosis

Novo Nordisk reports that the US Food and Drug Administration (FDA) approved a new indication for Wegovy (semaglutide) 2.4 mg injection to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis, excluding cirrhosis. The approval is meant to complement a reduced-calorie diet and increased physical activity.

“The clinical evidence seen in ESSENCE underscores the promise of this approach to treating adults with MASH with moderate to advanced liver fibrosis,” says Arun Sanyal, Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University.

The FDA decision is based on results from the phase 3 ESSENCE trial, which evaluated once-weekly Wegovy injections in adults with MASH and liver fibrosis stages F2 to F3 over 72 weeks. In the trial, 63% of participants receiving Wegovy (n=534) achieved resolution of steatohepatitis without worsening fibrosis, compared with 34% in the placebo group (n=266). 

Additionally, 37% of the treatment group saw improvement in fibrosis without steatohepatitis progression versus 22% on placebo. A secondary endpoint showed 33% of patients achieved both resolution of steatohepatitis and fibrosis improvement, compared with 16% on placebo. Overall, 83.5% of patients maintained the target dose of 2.4 mg throughout the study.

Globally, about one in three people living with overweight or obesity also have MASH, often presenting asymptomatically or with nonspecific early symptoms. Untreated, the condition may progress to cirrhosis, liver cancer, or the need for a transplant. 

Dave Moore, Executive Vice President of US Operations, Novo Nordisk, described the FDA approval as a pivotal milestone for the MASH community. He highlighted semaglutide’s expanding evidence base across chronic conditions including diabetes, obesity, cardiovascular disease, and chronic kidney disease.

Wegovy was initially approved in 2021 for adults with obesity or overweight with related medical conditions. Subsequent approvals expanded its use to adolescents aged 12 and older and, in 2024, to reduce major cardiovascular events in adults with heart disease and obesity or overweight. The accelerated approval addresses a new patient population with noncirrhotic MASH.

Both Wegovy and Ozempic reflect Novo Nordisk’s focus on metabolic and weight-related conditions.Ozempic is approved for adults with type 2 diabetes, while Wegovy is authorized for individuals with obesity or those who are overweight with weight-related health conditions. According to UNAM, Google Trends data indicates that searches for Ozempic in Mexico have steadily increased since 2022, peaking in March 2023. 

Novo Nordisk, which is marking 20 years of operations in Mexico, considers the country a strategic market due to its high obesity and diabetes prevalence. The company has also expanded its clinical trial activities in Mexico to support research and development in these areas.