CLEVELAND, Ohio- The U.S. Food and Drug Administration has granted approval of a drug that experts say marks a landmark shift in treatment for the most common form of liver disease.

Madrigal Pharmaceuticals, a small pharmaceutical company in Pennsylvania was granted approval for its one and only drug: Rezdiffra (resmetirom), the first and only approved drug for the treatment for a serious form of fatty liver disease in adults.

University Hospitals liver specialist Dr. Pierre Gholam said the drug is designed to help prevent progression to cirrhosis in persons with fatty liver who have already shown some liver dysfunction -- somewhere between 8 and 10 million patients. These patients often have difficulty losing weight, which up until Thursday was the only intervention proven to be effective.

This is a big deal because fatty liver is by far the leading condition we see in the treatment of liver disease, said Gholam, of the approval announced last week.

Out of 56 patients he saw in his liver clinic last week, 34 of them had fatty liver, he recounted. Where else do you see a situation where two-thirds of your patients have the exact same problem?

Fatty liver is seen most often in people who are overweight or obese and is becoming more common around the world, especially in Middle Eastern and Western nations as the number of people with obesity rises.

Initially there may be no symptoms, but some people with fatty liver can develop a more severe form of the disease called nonalcoholic steatohepatitis, or NASH. When this happens, the fat in the liver becomes toxic, and liver cells become inflamed and die. NASH can lead to cirrhosis, liver failure, the need for a transplant, and even death.

The new drug works by stimulating the thyroid to burn excess energy that the liver would otherwise store in the form of fat. In patients with NASH, it has been shown to prevent and even reverse liver damage.

However, it is not currently approved in patients whose liver damage has progressed to cirrhosis, and the dosage of certain other medications, like statins used for lowering cholesterol, may need to be adjusted. Madrigal says, they are currently investigating whether the drug can help patients with cirrhosis.

It doesnt work for every patient. It works for a subset of patients, explained Gholam. But when it does it reduces inflammation and scarring in the liver which is ultimately what leads to patients developing cirrhosis and getting sick from fatty liver disease.

The drug manufacturers say that it should not be considered a substitute for modifications in diet and exercise, but instead used as a complementary treatment to help nudge patients in the right direction. And for many patients this is a big relief.

On the morning following the FDAs announcement, Gholam says seven patients called his office asking if they could get on the drug, which demonstrates just how many people are desperate for a solution.

Its the first step after 15-20 years of trying and failing said Gholam. Its a small first step. We have not cured fatty liver disease and we certainly have not cured metabolic syndrome or obesity, but it is the first time that someone is going to come to my clinic with fatty liver with scarring and Ill be able to offer them something other than diet and exercise.

Unfortunately, 90%-95% of people who lose weight regain it within three to five years he says.

So it is not a realistic expectation for most people, Gholam said.

Gholam says this marks the beginning of what may be a turning point in the treatment of fatty liver disease, and hes hopeful that a decade from now, patients will have multiple options.

GLP-1 agonists, like the drugs liraglutide and semaglutide currently prescribed to treat obesity and diabetes are also being investigated for their ability to treat the liver along with several other classes of medications Gholam said. The studies should have results in the next 10-18 months.

Meanwhile, data on Rezdiffra will continue to be collected for the FDA over the course of a total of 54 month because it was approved under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and address an unmet medical need.

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When diet and exercise arent enough, new drug can treat fatty liver disease, says FDA - cleveland.com