06:40 AM EDT, 08/18/2025 (MT Newswires) -- Novo Nordisk's ( NVO ) US-listed shares rose early Monday as the Danish drugmaker said the US Food and Drug Administration granted its weight-loss drug Wegovy a new indication to treat a serious liver disease.

The FDA cleared Wegovy to treat adults with metabolic dysfunction-associated steatohepatitis, a serious form of fatty liver disease, with moderate to advanced liver scarring, in combination with a reduced calorie diet and increased physical activity, the company said Friday. Novo Nordisk's ( NVO ) shares on the New York stock exchange increased 2.8% in the most recent premarket activity.

The accelerated approval from the regulator is based on results from a phase 3 clinical trial evaluating the effects of Wegovy as a once-weekly injection on liver histology in patients suffering from the liver disease, according to the Danish firm.

The first primary endpoint of the study showed that 63% of patients treated with the drug achieved a resolution in steatohepatitis with no liver fibrosis worsening, compared with 34% on placebo. The second primary endpoint demonstrated a 37% improvement in liver fibrosis and no worsening of steatohepatitis versus 22% on placebo, the company said.

Roughly 83.5% of patients in the semaglutide group, the active ingredient in Wegovy, maintained the target dose of 2.4 mg until the 72nd week, Novo Nordisk ( NVO ) said. There is an ongoing study to confirm the clinical benefit of the drug in adults with metabolic dysfunction-associated steatohepatitis.

"The FDA's conditional approval of Wegovy for the treatment of adults with noncirrhotic MASH marks a truly pivotal milestone and a significant step forward for the MASH community and those seeking new options," Novo Nordisk's ( NVO ) vice president of US operations, Dave Moore, said in a statement. "This builds on the expanding body of evidence demonstrating the clinical benefits of semaglutide across a range of chronic conditions including diabetes, obesity, cardiovascular and chronic kidney disease."

The FDA first approved Wegovy in 2021 to treat adults with obesity or excess weight and expanded the drug's use to children aged 12 years and older the following year. In 2024, the product was cleared to be used by adults with known heart disease and either obesity or overweight to reduce the risk of major cardiovascular events such as death, heart attack or stroke.