Wegovy Gains FDA Approval for MASH, Boosting Novo Nordisk's Liver Treatment Portfolio

Novo Nordisk's drug Wegovy has received accelerated approval from the U.S. Food and Drug Administration for the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis, marking a significant milestone for the company. The approval, which does not cover cirrhosis, underscores the growing impact of MASH—a condition that affects many with overweight or obesity and can lead to severe liver complications if untreated.

The FDA's decision was influenced by findings from the Phase 3 ESSENCE trial, where Wegovy significantly improved liver fibrosis and resolved steatohepatitis without worsening liver fibrosis compared to placebo. The trial encompassed 800 participants, predominantly comprising white individuals with a mean age of 56 years, most of whom had type 2 diabetes and were taking medications for lipid management and weight loss in conjunction with other treatments. Notably, 63% of those treated with Wegovy achieved resolution of steatohepatitis without worsening liver fibrosis, demonstrating a clear benefit over placebo.

Additional outcomes of the trial showed improvement in liver fibrosis in 37% of Wegovy-treated individuals, compared to 22% in the placebo group. Furthermore, a substantial proportion of participants maintained the requisite dose of 2.4 mg throughout the 72-week study period. This outcome speaks to Wegovy's potential in addressing liver conditions that have long lacked effective medication options.

Beyond its new indication for MASH, Wegovy remains a prominent player in weight management and cardiovascular health. It is approved for adults and children from 12 years old with obesity, and it also helps reduce major cardiovascular event risks in adults with heart disease who are obese or overweight. These broadened indications underscore Wegovy's versatility and extensive reach, intended to help individuals manage excess body weight and its related medical challenges.

Looking ahead, Novo Nordisk has set its sights on geographic expansion, having sought regulatory approval in the European Union and Japan earlier in 2025. An FDA filing application for an oral version of semaglutide, the drug's active ingredient, reflects the company’s commitment to innovation and accessibility. Market dynamics are expected to evolve further with an anticipated outcome from part two of the ESSENCE trial in 2029, aiming to prove Wegovy's efficacy in reducing the risk of liver-related clinical events in patients with MASH and F2 or F3 fibrosis.

While the pharmaceutical market remains competitive, Wegovy's entry into MASH treatment is a game-changer, especially regarding potential synergies with existing obesity treatments. As the landscape of liver disease treatments continues to develop, Wegovy's approval highlights the FDA’s openness towards accelerating drug availability for conditions with significant public health implications.