Novo Nordisk's Wegovy Approved for Severe Liver Disease, Beats Eli Lilly

Novo Nordisk's (NVO.US) popular 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 positions Novo Nordisk ahead of its competitor Eli Lilly in bringing the drug to the U.S. market, as this condition is becoming increasingly prevalent in the country. The drug is indicated for adult patients with metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to severe liver fibrosis (stage 2 or 3) and are not cirrhotic.

The FDA stated in a release that this condition affects approximately 6% of U.S. adults, or about 14.9 million people. The drug is intended to be used in conjunction with a low-calorie diet and increased physical activity. The accumulation of fat in the liver can lead to fatty liver disease, which can cause inflammation and potentially progress to more serious conditions such as cirrhosis and liver cancer.

This approval gives Novo Nordisk another competitive edge in the rapidly growing GLP-1 drug market, which is favored for its weight management benefits. The new indication for treating liver disease could help Novo Nordisk expand its market share, as the company faces significant pressure to grow in a highly competitive environment, particularly from lower-priced generics and competitors like Eli Lilly.

In a study, Wegovy improved liver fibrosis in 37% of patients without worsening inflammation, compared to 22% of patients who received a placebo. The company stated that the proportion of patients whose inflammation was alleviated was nearly double that of patients who received a placebo.

Martin Holst Lange, Novo Nordisk's chief scientific officer, noted that about one-third of overweight or obese individuals are affected by this condition. He stated that Wegovy not only prevents the progression of the disease in these patients but also helps repair the damage to the liver.