Novo Nordisk's Wegovy Gains FDA Approval for Liver Disease Treatment, Expanding Access to Nearly 15 Million U.S. Patients

Novo Nordisk's (NVO.US) best-selling weight-loss drug Wegovy has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of a severe liver disease. This move by the company has outpaced its competitor, Eli Lilly (LLY.US), allowing Novo Nordisk to be the first to bring the drug to the U.S. market as the condition is becoming increasingly common in the country. The drug is indicated for adult patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) accompanied by moderate to severe hepatic fibrosis (stage 2 or 3).

FDA said in a statement on Friday that the condition affects about 6% of American adults, or approximately 14.9 million people. The drug is intended to be used in conjunction with a low-calorie diet and increased exercise. The accumulation of fat in the liver leads to fatty liver, which can cause inflammation and potentially lead to more serious conditions such as cirrhosis and liver cancer.

This approval gives Novo Nordisk another first-mover advantage in the rapidly growing GLP-1 drug market. Such drugs are widely favored for their ability to help control weight. The newly added indications, such as the one for treating liver disease, could potentially help Novo Nordisk expand its market share, as the company faces significant pressure to grow its market presence amidst fierce competition (especially from lower-priced generics and rival company Eli Lilly) in the current highly competitive landscape.

As of the time of writing, Novo Nordisk's after-hours trading rose by 7.14%. Meanwhile, Madrigal Pharmaceuticals (MDGL.US), which is developing treatments for the same condition, fell by approximately 7.53%.

In a study, Wegovy improved liver fibrosis in 37% of patients without exacerbating inflammation, compared to only 22% improvement in patients receiving a placebo. The company stated in a release that the proportion of patients taking the drug who experienced reduced inflammation was nearly double that of those on the placebo.

Novo Nordisk Chief Science Officer Martin Holst Lange said in a statement that about one-third of overweight or obese people are affected by this condition. He said that Wegovy not only prevented the worsening of these patients' conditions but also helped repair liver damage.