Novo Nordisk wins FDA approval for Wegovy to treat liver disease MASH.

Novo Nordisk has secured FDA approval for a label expansion of its weight loss therapy Wegovy to treat metabolic dysfunction-associated steatohepatitis (MASH), a liver disorder. This marks Wegovy's entry into the liver disease market. The approval is based on data from a clinical trial demonstrating the drug's efficacy in reducing liver inflammation and improving liver function in patients with MASH.

Novo Nordisk A/S has secured FDA approval for a label expansion of its weight loss therapy Wegovy (semaglutide) to treat metabolic dysfunction-associated steatohepatitis (MASH), a liver disorder. This marks Wegovy's entry into the liver disease market [1]. The approval is based on data from a clinical trial demonstrating the drug's efficacy in reducing liver inflammation and improving liver function in patients with MASH.

Wegovy, initially approved for obesity and overweight, has now been cleared for MASH, a progressive liver condition that affects around 6% of U.S. adults [2]. The FDA's accelerated approval was granted based on part 1 of the ESSENCE trial, which showed that 36.8% of patients treated with Wegovy achieved improvement in liver fibrosis with no worsening of steatohepatitis, compared to 22.4% treated with placebo. Additionally, 62.9% of patients on Wegovy achieved resolution of steatohepatitis with no worsening of liver fibrosis, compared to 34.3% on placebo [3].

The approval allows Wegovy to be used alongside a reduced-calorie diet and increased physical activity. The drug's mechanism of action in improving liver inflammation and scarring is not fully understood, but it is believed to promote weight loss and potentially other mechanisms [2].

Novo Nordisk, a leading global healthcare company, is committed to expanding the use of its medicines to defeat serious chronic diseases. With this approval, Wegovy now offers a new treatment option for people living with MASH, which affects more than 250 million people worldwide [3].

References:
1. Reuters. (2025, August 15). Novo Nordisk's Wegovy gets accelerated US approval for liver disease MASH. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisks-wegovy-gets-accelerated-us-approval-liver-disease-mash-2025-08-15/
2. FDA. (2025, August 15). FDA approves treatment for serious liver disease known as MASH. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-serious-liver-disease-known-mash
3. Yahoo Finance. (2025, August 15). Novo Nordisk's Wegovy approved by FDA for US treatment of noncirrhotic MASH. Retrieved from https://finance.yahoo.com/news/novo-nordisk-wegovy-approved-us-212300114.html