The U.S. Food and Drug Administration granted accelerated approval for Novo Nordisk’s once-weekly injection Wegovy to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis but no cirrhosis. The decision broadens the blockbuster GLP-1 receptor agonist’s label beyond obesity, weight-related cardiovascular risk reduction and other existing uses. Regulators based the ruling on Part 1 of the Phase 3 ESSENCE study, in which 63 percent of patients receiving Wegovy achieved resolution of steatohepatitis without worsening fibrosis, compared with 34 percent on placebo. Wegovy also improved fibrosis in 37 percent of treated patients versus 22 percent for placebo. A confirmatory second part of the trial, designed to show long-term clinical benefit, is ongoing. Wegovy becomes the first GLP-1 therapy cleared for MASH, a progressive liver disease that affects roughly one in 20 U.S. residents and can lead to cirrhosis, liver cancer or transplant. Novo Nordisk has submitted similar applications in the European Union and Japan earlier this year. Following the announcement, Novo Nordisk’s U.S.-listed shares advanced about 5–6 percent in post-market trading.