Wegovy® (semaglutide 2.4 mg), the first GLP-1 therapy approved for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (stages F2-F3), has received accelerated approval from the U.S. Food and Drug Administration (FDA), marking a significant milestone for Novo Nordisk. For the millions of people afflicted by this degenerative, silent liver disease, formerly known as NASH, this decision represents a turning point.
Details of the Approval
Results from part 1 of the ESSENCE phase 3 clinical trial, which demonstrated Wegovy’s statistically significant effectiveness in treating MASH, served as the foundation for the FDA’s approval. Over the course of 240 weeks, 1,200 participants were randomized 2:1 to receive either semaglutide 2.4 mg or a placebo, both of which were accompanied by a lower calorie intake and more exercise. The results of the 72-week interim analysis from the initial 800 patients were used to grant the current approval.
- Compared to 22.4% in the placebo group, 36.8% of patients treated with Wegovy® saw an improvement in liver fibrosis without a worsening of steatohepatitis.
- Compared to 34.3% of patients getting a placebo, 62.9% of patients on Wegovy® experienced a remission of steatohepatitis without a worsening of liver fibrosis.
What is MASH?
Over 250 million people worldwide suffer from metabolic dysfunction-associated steatohepatitis (MASH), a degenerative illness whose incidence is predicted to double in advanced stages by 2030. MASH affects one in three individuals who are overweight or obese, making it a pressing public health concern. In its early, asymptomatic stages, patients frequently go untreated. Untreated MASH increases the risk of liver-related morbidity and mortality by accelerating the development of severe fibrosis, cirrhosis, or liver cancer.
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The ESSENCE Clinical Program
A crucial study called the ESSENCE trial is assessing the effects of once-weekly subcutaneous semaglutide 2.4 mg in persons with moderate-to-advanced fibrosis and MASH. There are two components to the trial:
- Part 1: Highlighted improvements in liver histology at 72 weeks. The recent FDA approval was backed by the results.
- Part 2: Semaglutide’s capacity to reduce liver-related clinical outcomes over 240 weeks will be evaluated through 2029.
Read More: Novo Nordisk Seeks EU Approval for Higher Dose of Wegovy®, Promising Greater Weight Loss
Expanded Patient Impact for Wegovy®
Wegovy® was first authorized in 2021 to help adults with obesity or excess weight and associated comorbidities manage their weight. Since then, its use has spread to adolescents, cardiovascular risk reduction, and now the sizable population with MASH and liver fibrosis. The clearance is an important new therapeutic option for the roughly 22 million Americans who suffer from MASH.
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