Novo Nordisk's Wegovy Becomes First GLP-1 Therapy Approved for Liver Disease MASH

Key Insights

• The FDA granted accelerated approval for Novo Nordisk's Wegovy to treat metabolic dysfunction-associated steatohepatitis (MASH), making it the first GLP-1 therapy cleared for this serious liver condition.
• In a Phase 3 trial, 37% of patients on Wegovy showed improved liver fibrosis at 72 weeks compared to 22.4% on placebo, while 63% achieved liver inflammation resolution versus 34.3% for placebo.
• MASH affects approximately 5% of U.S. adults and can progress to serious or fatal outcomes when untreated, representing a significant unmet medical need.

Novo Nordisk announced Friday that the U.S. Food and Drug Administration has granted accelerated approval for Wegovy (semaglutide) to treat metabolic dysfunction-associated steatohepatitis (MASH), a serious liver condition. This landmark decision makes Wegovy the first GLP-1 class therapy cleared for MASH, opening a new therapeutic avenue for a progressive liver disease that affects around 5% of adults in the United States.

Clinical Trial Results Drive Approval

The FDA's approval was based on results from part one of a two-part Phase 3 study that demonstrated Wegovy's efficacy in treating MASH patients with liver scarring. The trial showed significant improvements compared to placebo across key liver health metrics.

At 72 weeks, nearly 37% of patients receiving Wegovy experienced improvement in liver fibrosis, compared to 22.4% of those on placebo. Even more striking, nearly 63% of Wegovy-treated patients achieved resolution of liver inflammation, versus 34.3% in the placebo group. Importantly, no worsening of the disease was observed in patients receiving the active treatment.

Addressing an Unmet Medical Need

MASH represents a significant clinical challenge, affecting roughly one in 20 people in the United States according to the American Liver Foundation. The condition is often asymptomatic or presents with nonspecific symptoms in early stages, frequently resulting in delayed diagnosis. When left untreated, MASH can progress to serious and sometimes fatal outcomes.

The approval specifies that Wegovy should be used alongside a reduced-calorie diet and increased physical activity for treating adults with MASH and liver scarring.

Regulatory Strategy and Market Expansion

The accelerated approval pathway allows the FDA to bring therapies targeting serious and life-threatening conditions to market more quickly. However, this approval mechanism has faced criticism as some drugs granted accelerated approval have later proven ineffective in confirmatory studies.

Novo Nordisk has pursued a global regulatory strategy for this indication, filing for approval with the European Union in February and submitting applications in Japan in May. The company is expanding Wegovy's therapeutic profile beyond its existing indications for weight loss and cardiovascular risk reduction in adults with heart disease or obesity.

Clinical Significance

This approval represents the first targeted therapy option for MASH patients within the GLP-1 drug class, potentially transforming treatment approaches for this progressive liver condition. The substantial differences in efficacy outcomes between Wegovy and placebo suggest meaningful clinical benefits for patients with this serious hepatic disorder.