#United States #FDA Approval #MASH #Wegovy #Plainsboro

Wegovy® Receives FDA Approval for MASH Treatment

On August 15, 2025, Novo Nordisk announced the FDA's approval of Wegovy® (semaglutide) for adults suffering from metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis, not cirrhosis. This development is significant as Wegovy® is the first glucagon-like peptide-1 receptor agonist (GLP-1 RA) approved for this condition.

What is MASH?

MASH is a form of fatty liver disease that can lead to severe complications, including cirrhosis and even liver cancer if not treated appropriately. While some patients remain asymptomatic, many show vague symptoms, which contributes to delayed diagnosis and treatment. In the United States, approximately one in 20 individuals is affected by MASH, which is especially prevalent among those who are overweight or obese.

Clinical Evidence from the ESSENCE Trial

The FDA's approval followed the successful outcomes of the phase 3 ESSENCE trial, which studied the impact of weekly 2.4 mg injections of Wegovy® on liver health over 72 weeks in patients with moderate to advanced liver fibrosis.

Key findings from the study revealed that:

• - 63% of participants treated with Wegovy® experienced resolution of steatohepatitis without a worsening of liver fibrosis compared to 34% in the placebo group.
• - Further, 37% showed an improvement in liver fibrosis without a worsening of steatohepatitis while only 22% of the placebo group showed similar results.
• - Overall, 83.5% of the Wegovy® group maintained the target dose for the treatment period, showcasing the drug's tolerability and effectiveness.

Despite these promising results, the FDA's approval is conditional, pending further confirmation from ongoing studies assessing Wegovy’s long-term benefits in MASH patients.

Statement from Experts

Dr. Arun Sanyal, Director at the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, remarked, “The FDA’s decision marks a substantial step forward in how we understand and treat patients with MASH. The success seen in the ESSENCE trial speaks to the potential benefits of Wegovy®.”

Dave Moore, Executive VP of US Operations, stated, “This pivotal milestone facilitates focused alternative treatments for the MASH community and addresses an ongoing health crisis that has long been overlooked.”

Wegovy® Background

Initially approved by the FDA in 2021, Wegovy® was designed to aid adults in their weight loss journey alongside a restricted diet and increased exercise. Subsequently, its indication widened to include children aged 12 or older in 2022 and adults with known cardiovascular issues in 2024.

The approval for treating MASH represents a critical expansion of Wegovy®'s applications beyond obesity and heart-related indications, solidifying its role in a multifaceted approach to metabolic health.

Conclusion

The approval of Wegovy® for treating MASH signifies a new avenue of hope for many individuals grappling with this serious health condition, offering additional options for managing and potentially reversing the complications associated with liver fibrosis. As studies continue to confirm its efficacy, Wegovy® may pave the way for comprehensive treatment strategies in the future. Immerse yourself in the journey of continuous improvement and watch for updates on Wegovy® as Novo Nordisk continues to lead in innovative healthcare solutions.