U.S. FDA Approves Novo Nordisk’s Wegovy® (semaglutide) For The Treatment Of Metabolic Dysfunction-Associated Steatohepatitis (MASH), Expanding Its Indications Beyond Obesity

Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for an additional indication of Wegovy® (semaglutide 2.4 mg). The approval allows the use of Wegovy® for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) who also have moderate to advanced liver fibrosis, consistent with stages F2 to F3. This treatment is intended to be used alongside a reduced-calorie diet and increased physical activity.

The approval is supported by results from part 1 of the ESSENCE trial, which demonstrated that Wegovy® delivered significant clinical benefits compared to placebo. The data showed that by week 72, 36.8 percent of patients treated with Wegovy® achieved an improvement in liver fibrosis without worsening of steatohepatitis, compared to 22.4 percent in the placebo group. Additionally, 62.9 percent of patients receiving Wegovy® achieved resolution of steatohepatitis without worsening of fibrosis, whereas only 34.3 percent of patients in the placebo group reached the same outcome.

Martin Holst Lange, executive vice president, chief scientific officer and head of Research and Development, at Novo Nordisk, mentioned, “Wegovy® is now uniquely positioned as the first and only GLP-1 treatment approved for MASH, complementing the already proven weight loss, cardiovascular benefits and extensive body of evidence linked to semaglutide. MASH represents a significant health burden, with one in three people with overweight or obesity worldwide affected. In the US alone, around 22 million people are estimated to live with MASH. With the approval of Wegovy® for MASH, we provide a new treatment to people living with MASH that not only halts the disease activity but helps reverse the damage caused to the liver.”

These findings highlight the effectiveness of Wegovy® in addressing both liver fibrosis and steatohepatitis in people living with MASH. With this decision, Wegovy® is now available in the United States as a treatment option for adults with MASH, providing a new therapeutic pathway for managing this complex liver disease.