The FDA Has Approved a New Treatment for a Liver Disease Called MASH (Metabolic Dysfunction-Associated Steatohepatitis)

Fatty liver disease isn’t just one condition. It’s a continuum. At a minimum, it involves the accumulation of fat in liver cells, but it may progress to a more serious condition involving fibrosis, or scarring. The condition now goes by the abbreviation MASLD, which stands for metabolic dysfunction-associated steatotic liver disease. 

The Food and Drug Administration recently approved a drug that has shown significant promise in treating the more severe type of MASLD, called MASH, which stands for metabolic dysfunction-associated steatohepatitis. MASH is likely to cause liver scarring and may eventually lead to cirrhosis, a serious condition marked by extensive scarring of the liver as a result of years of damage from inflammation. 

The terms MASLD and MASH are replacements for NAFLD (non-alcoholic fatty liver disease) and NASH (non-alcoholic steatohepatitis). Patients seeking information about these conditions may see both the old and the new terms used. Even though the names have changed, the diseases are the same.  

Dr. Danielle Brandman, Medical Director of the Center for Liver Disease and Transplantation at Weill Cornell Medicine, offers the following insights where MASLD is concerned and answers your FAQs, especially in light of the newly approved treatment for MASH. 

Is MASLD serious? 

The good news about MASLD, says Dr. Danielle Brandman, Medical Director of the Center for Liver Disease and Transplantation at Weill Cornell Medicine, is that it can get better and even be completely reversible through changes in eating habits and exercise, and the weight loss resulting from these changes.  

However, if a patient’s liver damage from MASLD progresses to cirrhosis, with its extensive scarring and damage, that is much more difficult to reverse, she says. Having cirrhosis increases the risk of liver failure or liver cancer—especially hepatocellular carcinoma (HCC), the most common type of liver cancer. Liver failure and/or liver cancer may result in the need for a life-saving liver transplant. 

How prevalent are MASLD and its subtype, MASH?  

MASLD affects 25 to 30 percent of the U.S. population, while MASH affects roughly a quarter of those with MASLD. 

How is the newly approved treatment for MASH different from other available treatments? 

The recently approved treatment, called resmetirom, is the first medication to specifically treat MASH and fibrosis.  

“Other medications and supplements previously recommended for the treatment of MASH were studied using different endpoints—outcomes identified by the researchers who authored the studies. That’s why it’s difficult to compare these treatments head-to-head with resmetirom.  

“The clinical trial of resmetirom is ongoing,” she adds, “so the data are still being collected and analyzed. We’ll learn more and more about the new drug as the trial unfolds over the next couple of years.” 

What is your opinion of the data thus far?  

“It’s encouraging to see a medication that has a significant impact on the endpoints used to measure the effectiveness of MASLD drugs. It has been extremely challenging to find drugs that are safe and effective, and many have failed in earlier stages of drug development.” 

Who is a candidate for the drug? Who isn’t? 

Currently, resmetirom is approved for patients with MASH and stage 2-3 fibrosis. “A liver biopsy is not required to receive the drug, but your doctor may choose to do one if they think it is necessary to accurately determine how much liver scarring you have,” she says. 

Should people be screened for MASLD? 

While the American Association for the Study of Liver Diseases (AASLD) does not officially recommend routine screening of all patients for MASLD, the organization does recommend that doctors actively check their at-risk patients for the disease. Because patients with diabetes and metabolic syndrome are considered at higher-than-usual risk for MASH and potentially rapid progression to cirrhosis, screening may be beneficial. 

Primary care providers (PCPs) can screen for MASLD via blood tests to assess a patient’s liver enzymes and order an abdominal ultrasound, if needed. If MASLD is suspected, your PCP can check your platelets to help determine if there’s significant damage. If that turns out to be the case, it’s time to make an appointment with a hepatologist. 

What are the symptoms of MASLD? 

“Most patients with MASLD have no symptoms,” says Dr. Brandman. “When they do, the most common ones are fatigue and abdominal pain on the right side.  

“Those with cirrhosis and resulting liver failure may experience jaundice—yellowing of the skin or eyes—along with fluid retention, bleeding and confusion,” she adds. 

Why does the FDA state that resmetirom needs to be combined with diet and exercise? 

“Changes in eating habits and physical activity are still the cornerstone of MASLD management,” Dr. Brandman says. “These two behaviors aid in weight management, and they may have additional favorable effects on liver health. Because weight and body fat influence MASLD, it is important for patients to try to control their weight. Finally, because resmetirom exclusively targets liver disease, healthy eating habits and exercise are likely to benefit other health problems related to excess weight and body fat.” 

What are the latest guidelines on diet and exercise? 

Losing weight can be challenging, but it’s the best treatment on offer for MASLD, she says.   

See the latest guidelines below, especially as these apply to MASLD and MASH: 

Diet and nutrition 

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