Wegovy? approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis

發(fā)布時間： 2025-08-18 閱讀：11次

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Aug. 15, 2025 -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a new indication for Wegovy? (semaglutide) injection 2.4 mg, treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced calorie diet and increased physical activity.

The accelerated approval is based on Part 1 of the ESSENCE trial, in which Wegovy? demonstrated a statistically significant improvement in liver fibrosis (liver scarring) with no worsening of steatohepatitis, as well as resolution of steatohepatitis with no worsening of liver fibrosis compared to placebo.

The FDA initially approved Wegovy? in 2021 with a reduced calorie meal plan and increased physical activity to help adults with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to lose weight and keep the weight off. The indication was expanded in 2022 to include children aged 12 years and older with obesity. In 2024, Wegovy? was approved to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight.1 Today, the FDA has granted accelerated approval for Wegovy? for a new patient population to treat adults with MASH with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.