FDA Grants Accelerated Approval of Wegovy to Treat Liver Disease

The FDA has granted accelerated approval for a new indication for Wegovy (semaglutide) injection 2.4 mg: to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis). It is not approved for patients with cirrhosis of the liver. Developed by Novo Nordisk, Wegovy is the first GLP-1 drug approved to treat MASH. An ongoing study aims to confirm the clinical benefit of Wegovy in adults with MASH.

MASH — also called nonalcoholic steatohepatitis (NASH) — is a severe form of fatty liver disease. It affects between 1.5% and 6.5% of U.S. adults. The number of people in advanced stages of the disease is expected to double by 2030.

Arun Sanyal, M.D.

“If left untreated, MASH can lead to serious and potentially fatal outcomes. The clinical evidence seen in ESSENCE underscores the promise of this approach to treating adults with MASH with moderate to advanced liver fibrosis,” Arun Sanyal, M.D., director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at the Virginia Commonwealth University, said in a news release.

People living with MASH are often asymptomatic or present with nonspecific symptoms in the early stages of the disease. Left untreated, MASH can lead to cirrhosis, liver cancer, and the need for a liver transplant. Among people who are living with overweight or obesity worldwide, one in three also have MASH.

Related: Semaglutide Improves Liver Fibrosis in New Trial Analysis

The conditional approval of Wegovy in this indication was based on results of the phase 3 ESSENCE trial, which studied once-weekly Wegovy on liver histology in adults with MASH and moderate to advanced liver fibrosis. At week 72, 62.9% of people treated achieved resolution of steatohepatitis with no worsening of liver fibrosis compared with 34.1% on placebo. Additionally, 37% of those treated with Wegovy achieved improvement in liver fibrosis with no worsening of steatohepatitis compared with 22.5% of patients on placebo.

ESSENCE is a two-part study with 1,197 patients who were randomized to receive Wegovy or placebo, on top of standard of care for 240 weeks. In Part 1, the primary objective was to demonstrate that treatment with Wegovy improves liver histology compared with placebo at week 72. In Part 2, which is ongoing, the primary objective is to demonstrate that treatment with Wegovy lowers the risk of liver-related clinical events compared with placebo in adults with MASH and moderate to advanced liver fibrosis at 240 weeks.

The FDA initially approved Wegovy in 2021 to help adults with obesity to lose weight. The indication was expanded in 2022 to include children aged 12 years and older with obesity. In 2024, Wegovy was approved to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in those with heart disease and for those who are overweight.

Wegovy has a list price of $1,349; the company says that 90% of patients with commercial insurance have a co-pay of $0 to $25 per month. For self-pay patients, Novo Nordisk offers Wegovy at $499 per month.

In 2024, sales of Wegovy and Novo Nordisk’s other semaglutide products (Ozempic and Rybelsus, which both treat type 2 diabetes) increased 27% to $39.4 billion. Sales of Wegovy alone grew 57% to $9.4 billion.

The three semaglutide drugs are at the top of CMS's next 15 Medicare Part D drugs to be subject to price negotiations as part of the Inflation Reduction Act. The new prices will become effective in 2027. The three semaglutide products had total Part D gross costs of $14.4 billion from November 2023 to October 2024, according to CMS.