Wegovy is now approved by the FDA to treat metabolic-associated steatohepatitis in adults with moderate-to-advanced fibrosis but without cirrhosis.

Novo Nordisk stock jumped Monday after the FDA approved the company's obesity drug, Wegovy, as a treatment for MASH.

With a new endorsement from the FDA, Novo Nordisk’s Wegovy has picked up its third indication and become the second drug approved in a severe form of fatty liver disease. | The FDA has signed off on an accelerated approval for Novo Nordisk's Wegovy to treat certain adults with metabolic-associated steatohepatitis.

The FDA clearance sets Novo’s medicine up a market battle with Madrigal Pharmaceuticals’ fast-selling Rezdiffra.

The label expansion could help Novo Nordisk “help shift the momentum” for Wegovy, after a difficult start to 2025, according to analysts at BMO Capital Markets.

The approval was based on Part 1 (72 week data) of the randomized, double-blind, placebo-controlled phase 3 ESSENCE trial.

Novo Nordisk's Wegovy has received accelerated approval for use in patients with metabolic dysfunction-associated steatohepatitis (MASH).

The glucagon-like peptide-1 (GLP-1) receptor agonist gained accelerated approval for patients with MASH and moderate to advanced liver fibrosis but no cirrhosis, to be given as a once-weekly, 2.4-mg subcutaneous injection alongside diet and exercise, drugmaker Novo Nordisk noted.

Novo Nordisk said on Friday the U.S. Food and Drug Administration has granted accelerated approval for its weight-loss drug Wegovy to treat a serious liver condition called metabolic dysfunction-associated steatohepatitis,