The FDA has granted accelerated approval to semaglutide (Wegovy; Novo Nordisk) injection 2.4 mg for the treatment of adults with metabolic dysfunction–associated steatohepatitis (MASH) with moderate to advanced liver fibrosis, making it the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for this indication. 1

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.

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

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’s stock popped Monday after it announced a cash discount for uninsured Ozempic users and gained FDA approval for Wegovy to be used for liver treatment. The pharma giant's stock rose more than 5.

FDA has approved Novo Nordisk's Wegovy, one-weekly 2.4 mg semaglutide injection for treating metabolic-associated steatohepatitis (MASH) in adults. Know how the approval was given and what it means for Wegovy's future as a weightloss and diabetes drugs.