US EditionWegovy® Approved by FDA for the Treatment of Adults with Noncirrhotic MASH with Moderate to Advanced Liver Fibrosis
Wegovy improves liver fibrosis and resolves steatohepatitis in adults with MASH, a condition affecting 1 in 20 people in the US, based on clinical trial results, FDA said.
- In a landmark move, the US Food and Drug Administration approved Wegovy injection 2.4 mg on Aug. 15, 2025, for noncirrhotic MASH with fibrosis.
- MASH affects approximately one in 20 Americans and can lead to cirrhosis, liver cancer, or liver transplant if untreated.
- In the ESSENCE trial, nearly 63% of patients on Wegovy achieved steatohepatitis resolution versus 34.3% on placebo, and nearly 37% showed fibrosis improvement versus 22.4%.
- With the green light, Wegovy is now available in the US for adults with MASH, providing hepatologists a powerful tool under its conditional approval while confirmatory studies proceed.
- Looking ahead, the approval could open access for roughly 16 million Americans and reinforce its first-mover lead, as Novo Nordisk seeks approval in Europe and Japan.
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Novo Nordisk Wegovy approved by USFDA for adults with noncirrhotic MASH with liver fibrosis
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Leaning Left12Leaning Right6Center23Last UpdatedBias Distribution56% Center
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C 56%
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