==Novo Nordisk (NVO) : FDA approves Wegovy for the treatment of noncirrhotic MASH

• Noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH), refers to cases of MASH without progression to cirrhosis (fibrosis stage F4). 
• Novo Nordisk estimates that over 250 million people worldwide live with MASH, though this figure includes both noncirrhotic and cirrhotic cases. The proportion of noncirrhotic MASH is not explicitly isolated in this figure but is likely a significant subset, as cirrhosis (F4) is a later stage of disease progression.

FDA approves a new indication for Wegovy; approved for the treatment of noncirrhotic MASH with moderate to advanced liver fibrosis

• Co announces that the FDA has approved a new indication for Wegovy (semaglutide) injection 2.4 mg, making it the first and only GLP-1 RA FDA-approved to treat adults with 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.
• This indication is approved based on improvement of MASH and liver scarring (fibrosis). There is an ongoing study to confirm the clinical benefit of Wegovy in adults with MASH.
• This FDA approval is based on results from the phase 3 ESSENCE trial investigating the effects of once-weekly Wegovy 2.4 mg injection on liver histology in adults with MASH and moderate to advanced liver fibrosis (stage F2 to F3) at Week 72.

MASH represents a significant health burden in the US, affecting approximately one in 20 people. People living with MASH are often asymptomatic or present with nonspecific symptoms in the early stages of the disease, which may result in a delayed diagnosis.  Left untreated, MASH can progress to serious and even fatal outcomes, such as cirrhosis, liver cancer, and the need for liver transplant.  Among people who are living with overweight or obesity worldwide, one in three also have MASH.

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.

In February 2025, Novo Nordisk also filed for regulatory approval in the EU, followed by regulatory submission in Japan in May 2025.