New Indication for Semaglutide

A new indication has been added to the Wegovy® (semaglutide) product information.  Provisional approval has been granted for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis. This condition (previously known as non-alcoholic steatohepatitis) is characterised by hepatic fat accumulation with inflammation and liver cell injury. Without effective management, MASH may progress to cirrhosis and hepatocellular carcinoma.

The goals of MASH management include weight loss (for overweight patients) and optimisation of blood pressure, blood glucose and lipid levels. Sustained weight loss of at least 10% is associated with particularly beneficial effects on disease activity.

This new indication is supported by positive results from the ESSENCE trial. In this double-blind study, patients with MASH and moderate or advanced liver fibrosis were randomly assigned to receive semaglutide 2.4 mg once weekly or placebo. After 72 weeks, 62.9% of patients in the semaglutide group achieved resolution of steatohepatitis with no worsening of liver fibrosis, compared with 34.3% in the placebo group. A reduction in liver fibrosis with no worsening of steatohepatitis was reported in 36.8% of the semaglutide group and 22.4% the placebo group.

No new safety signals emerged, and the safety profile was consistent with the known effects of semaglutide. Gastrointestinal adverse events were the most commonly reported, including nausea, diarrhoea, and constipation.