05:17 AM EDT, 08/18/2025 (MT Newswires) -- Novo Nordisk ( NVO ) said Friday the US Food and Drug Administration approved a new indication for semaglutide to treat adults with metabolic-dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis, without cirrhosis.

The approval uses the accelerated pathway based on part 1 of the phase 3 Essence study and requires confirmatory evidence from the ongoing trial, the company said.

At Week 72, 63% on semaglutide achieved resolution of steatohepatitis without fibrosis worsening versus 34% on placebo, and 37% achieved fibrosis improvement without steatohepatitis worsening versus 22% on placebo, Novo Nordisk ( NVO ) said.

A secondary measure showed 33% achieved both endpoints versus 16% on placebo, with 83.5% maintaining the 2.4 mg dose through Week 72, it added.

Wegovy, or semaglutide, is also indicated for chronic weight management in adults and children 12 and older and to reduce major cardiovascular events in adults with heart disease and obesity or overweight, the company added.

Shares of the company rose more than 4% in recent premarket activity Monday.

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