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Novo Nordisk's Wegovy® Receives First-of-its-Kind FDA Approval for MASH
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Novo Nordisk announced a significant milestone with the U.S. Food and Drug Administration's (FDA) accelerated approval of an additional indication for its drug, Wegovy® (semaglutide 2.4 mg). This approval specifically targets the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (stages F2 to F3). This marks a pivotal moment for patients, as Wegovy® is now the first and only GLP-1 treatment to be approved for MASH, a serious and progressive liver disease.

The accelerated approval was based on compelling data from Part 1 of the Phase 3 ESSENCE trial. This study evaluated the effect of once-weekly semaglutide 2.4 mg in adults with MASH and moderate to advanced liver fibrosis. The results demonstrated a statistically significant and superior improvement in key liver health markers for patients on Wegovy® compared to a placebo. 36.8% of patients treated with Wegovy® experienced an improvement in liver fibrosis without a worsening of steatohepatitis, compared to only 22.4% in the placebo group. 62.9% of patients on Wegovy® achieved resolution of steatohepatitis without a worsening of liver fibrosis, which was a significant improvement over the 34.3% in the placebo group. These results highlight the drug's ability not only to halt disease progression but also to help reverse the damage to the liver.

Metabolic dysfunction-associated steatohepatitis (MASH) is a serious, progressive liver disease that can be fatal if not properly managed. It is often asymptomatic in its early stages, leading to delayed diagnosis. MASH affects more than 250 million people worldwide, with an estimated 22 million living with the condition in the U.S. alone. The number of individuals with advanced stages of MASH is projected to double by 2030, underscoring the urgent need for effective treatments. People living with MASH, particularly those who are overweight or have obesity, face a higher risk of developing advanced liver disease, including liver cancer.

According to Novo Nordisk's Martin Holst Lange, this approval uniquely positions Wegovy® as a multifaceted treatment that addresses not only MASH but also offers proven benefits for weight loss and cardiovascular health.

As of the announcement date, Wegovy® is available in the U.S. for the treatment of MASH. This new indication expands the drug's portfolio, which already includes approvals for chronic weight management in adults and adolescents, and for reducing the risk of major cardiovascular events in adults with known heart disease. Novo Nordisk has also submitted regulatory applications for Wegovy® for the MASH indication in the EU and Japan.



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