FDA Approves Wegovy for Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)

NVO
November 01, 2025

On August 21, 2025, the U.S. FDA approved Wegovy for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (F2 to F3). This marks a significant expansion of Wegovy's therapeutic indications.

This approval makes Wegovy the first and only GLP-1 treatment approved for MASH, a condition affecting one in three people with overweight or obesity. The ESSENCE trial demonstrated statistically significant and superior improvements in both MASH resolution and liver fibrosis.

The new indication opens a substantial new market opportunity for Novo Nordisk, addressing a vast unmet medical need. This strategic approval reinforces Wegovy's versatility and strengthens Novo Nordisk's leadership in metabolic health beyond just weight loss.

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