The U.S. Food and Drug Administration on 15 Aug. granted accelerated approval for Novo Nordisk’s Wegovy (semaglutide) to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis, expanding the blockbuster weight-loss drug beyond obesity. The decision makes Wegovy the first therapy in the GLP-1 class cleared for the progressive liver disease, which affects roughly 5 % of U.S. adults. Regulators based the clearance on data from the Phase 3 ESSENCE trial. After 72 weeks, 63 % of patients receiving semaglutide achieved resolution of MASH without worsening fibrosis compared with 34 % on placebo, while 37 % showed an improvement in fibrosis with no disease progression versus 22.5 % for placebo. Wegovy is to be used alongside reduced-calorie diets and increased physical activity. Analysts estimate the new indication could open a market worth about $30 billion, giving the Danish drugmaker an early lead over Eli Lilly, whose tirzepatide is still in mid-stage testing for MASH. Novo Nordisk’s shares rose as much as 5 % in Copenhagen on 18 Aug., extending a 7 % after-hours gain when the news broke; Lilly slipped about 1.2 % in pre-market trading. Novo Nordisk has also sought approvals for the MASH use of Wegovy in Europe and Japan. Under the FDA’s accelerated pathway, the company must provide confirmatory data to maintain the U.S. authorization.