Novo Nordisk's (NVO) injectable weight-loss drug Wegovy has been approved in the U.S. for a new indication targeting a major health burden.
The FDA has granted accelerated approval to Wegovy injection 2.4 mg to treat adults with metabolic dysfunction-associated steatohepatitis with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced-calorie diet and increased physical activity. Wegovy becomes the first and only glucagon-like peptide-1 receptor agonist (GLP-1 RA) to be approved by the FDA to treat adults with noncirrhotic MASH with moderate to advanced liver fibrosis.
Metabolically-dysfunction-associated steatohepatitis (MASH) is a serious and often silent form of fatty liver disease that affects around 1 in 20 people in the United States. Among individuals living with overweight or obesity, 1 in 3 also have MASH. If left untreated, the disease can progress to life-threatening conditions such as cirrhosis, liver cancer, or even the need for a liver transplant. Madrigal Pharmaceuticals' Rezdiffra, a thyroid hormone receptor-beta (THR-beta) agonist approved by the FDA in March 2024, is the first approved treatment for adults with noncirrhotic MASH with moderate to advanced liver fibrosis. The drug, intended to be used in combination with diet and exercise, was also approved under the FDA's accelerated approval pathway.
The accelerated approval for Wegovy in the indication of MASH was granted based on results from Part 1 of the company's trial, dubbed ESSENCE.
ESSENCE is a two-part phase 3 trial evaluating the effect of once-weekly subcutaneous Wegovy 2.4 mg in adults with metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis. In Part 1, the primary objective was to demonstrate that treatment with Wegovy 2.4 mg improves liver histology compared with placebo in patients with MASH and fibrosis stage 2 or 3. In Part 2, which is ongoing, the primary objective is to demonstrate that treatment with Wegovy 2.4 mg lowers the risk of liver-related clinical events compared to placebo in adults with MASH and moderate to advanced liver fibrosis at 240 weeks.
In Part 1 of the ESSENCE trial, Wegovy demonstrated a statistically significant improvement in liver fibrosis (liver scarring) with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis compared to placebo, according to the company.
Wegovy was first approved by the FDA in 2021 for use alongside a reduced-calorie diet and increased physical activity to help adults with obesity or overweight - who also have weight-related health problems - lose weight and keep the weight off. In 2022, its approval was extended to include adolescents aged 12 and older. In 2024, the drug's indication was further expanded to include the reduction of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and who are either obese or overweight.
How is Wegovy faring in terms of sales?
Wegovy generated annual sales of 58.21 billion Danish kroner in 2024. The drug's sales rose to 36.89 billion Danish kroner in the first half of 2025, from 21.04 billion kroner in the same period last year.
NVO closed Friday's trading at $52.41, up 2.87%. In premarket trading on Monday, the stock is up 2.70%.
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