FDA grants accelerated approval to Wegovy for MASH with moderate to advanced fibrosis

The FDA approved semaglutide 2.4 mg (Wegovy) for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH, an inflammatory fatty liver disease) with stage F2 to F3 fibrosis, the first GLP-1 drug approved for the condition. In part 1 of the ESSENCE trial of 1,197 people, 63% on semaglutide had resolution of steatohepatitis without worsening fibrosis versus 34% on placebo, and 37% versus 22% had improved fibrosis at 72 weeks. Continued approval depends on part 2 of ESSENCE, which tracks liver-related clinical events.