FDA approves Wegovy for MASH with moderate to advanced liver fibrosis

The FDA has approved Wegovy (semaglutide) injection 2.4 mg to treat adults with MASH with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced calorie diet and increased physical activity. This indication is approved based on improvement of MASH and liver scarring (fibrosis). There is an ongoing study to confirm the clinical benefit of Wegovy in adults with MASH.

This FDA approval is based on results from the phase 3 ESSENCE trial investigating the effects of once-weekly Wegovy 2.4 mg injection on liver histology in adults with MASH and moderate to advanced liver fibrosis (stage F2 to F3) at Week 72. The first primary endpoint showed 63% of people treated with Wegovy 2.4 mg injection (n=534) achieved resolution of steatohepatitis and no worsening of liver fibrosis compared to 34% on placebo (n=266) with a statistically significant difference in response rate vs placebo of 29 (95% CI, 21;36).

Additionally, the second primary endpoint showed 37% of people treated with Wegovy 2.4 mg achieved improvement in liver fibrosis and no worsening of steatohepatitis compared to 22% on placebo with a statistically significant difference in response rate vs placebo of 14 (95% CI, 8;21). A confirmatory secondary endpoint at Week 72 showed 33% of patients treated with Wegovy 2.4 mg achieved both resolution of steatohepatitis and improvement in liver fibrosis compared to 16% on placebo with a statistically significant difference in response rate vs placebo of 17 (95% CI, 10;23). A total of 83.5% of the patients in the semaglutide group maintained the target dose of 2.4 mg until Week 72.

"Today's decision by the FDA reflects the continued progress in how we understand and treat patients with MASH, bringing us closer to care that meets the needs of people living with this disease," said Dr Arun Sanyal, Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University. "If left untreated, MASH can lead to serious and potentially fatal outcomes. The clinical evidence seen in ESSENCE underscores the promise of this approach to treating adults with MASH with moderate to advanced liver fibrosis."

In February 2025, Novo Nordisk also filed for regulatory approval in the EU, followed by regulatory submission in Japan in May 2025.