Novo Nordisk’s Wegovy Gains FDA Approval for Liver Disease Treatment

WATERBURY, Vermont — Shares of Novo Nordisk rose by nearly 5% on Monday after the company announced that its Wegovy obesity drug received accelerated approval from the U.S. Food and Drug Administration (FDA) to treat a serious liver disease. This announcement came on the heels of the company’s Friday statement detailing the approval for treating metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis.

The approval makes Wegovy the first treatment in the GLP-1 class to be authorized for MASH, a progressive liver condition affecting about 5% of U.S. adults, according to the American Liver Foundation. This development expands Wegovy’s applications beyond diabetes and obesity treatment, potentially enhancing its position in the metabolic disease market.

Martin Holst Lange, Novo Nordisk’s executive vice president and chief scientific officer, expressed optimism about the approval, stating, “Wegovy is now uniquely positioned as the first and only GLP-1 treatment approved for MASH, complementing the already proven weight loss and cardiovascular benefits of semaglutide.”

The accelerated approval is based on findings from the first phase of the ESSENCE trial, where Wegovy showed a statistically significant improvement in liver fibrosis compared to placebo. Under the trial, almost two-thirds (62.9%) of participants receiving Wegovy achieved the resolution of steatohepatitis without worsening liver fibrosis, compared to 34.3% of those on a placebo.

Additionally, 36.8% of Wegovy-treated subjects saw an improvement in liver fibrosis with no worsening of steatohepatitis after 72 weeks, outperforming the 22.4% improvement rate in the placebo group. The second phase of the study is expected to conclude in 2029.

Starting immediately, Wegovy will be available in the U.S. for the treatment of MASH. Currently, the only other FDA-approved treatment for MASH is Madrigal Pharmaceuticals’ Rezdiffra, which received clearance in 2024.