Wegovy Wins FDA Approval for Severe Liver Disease MASH

Novo Nordisk’s popular weight-loss drug Wegovy has just received a new approval from the U.S. Food and Drug Administration (FDA)—this time for treating a serious liver condition called metabolic dysfunction-associated steatohepatitis (MASH). This marks Wegovy’s third approved use, following its approvals for obesity and reducing cardiovascular risk.

MASH, once known as NASH, is caused by excess fat in the liver, which leads to inflammation and scarring. If left untreated, it can progress to cirrhosis, liver cancer, or even the need for a transplant. According to Novo, the disease affects about 1 in 20 Americans and nearly 1 in 3 people worldwide who are overweight or obese.

The FDA granted Wegovy accelerated approval for adults with MASH and moderate to advanced liver scarring, but not cirrhosis. The treatment must be paired with a reduced-calorie diet and increased physical activity. Approval was based on positive results from the ongoing Essence trial, where once-weekly Wegovy showed strong benefits compared to placebo. After 72 weeks, 63% of patients on Wegovy saw their MASH resolve without worsening scarring, versus just 34% on placebo. The drug also improved fibrosis in 37% of patients, compared to 22% with placebo.

While Madrigal Pharmaceuticals’ Rezdiffra was the first drug approved for MASH in the U.S., Wegovy now joins the market with a different approach. Rezdiffra works by directly targeting the liver, while Wegovy, a GLP-1 drug, mimics a natural hormone to reduce inflammation and fat in the liver.

Analysts expect high demand for MASH treatments, given the disease’s growing prevalence. Even though Wegovy was second to cross the FDA finish line, experts believe the market is large enough for multiple treatment options. Novo has also filed for approvals in Europe and Japan.

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