FDA Approves First Drug To Treat a Common, Serious Liver Condition

(CTN News) – The FDA’s first approved drug for treating liver scarring caused by common diseases is now available to millions of Americans, the Federal Drug Administration announced Thursday.

There is a condition known as non-cirrhotic non-alcoholic steatohepatitis (NASH). It is estimated that up to 8 million Americans are affected by NASH with liver scarring. The FDA explained in a statement that it is often related to high blood pressure and type 2 diabetes.

“Previously, patients with NASH who had significant liver scarring couldn’t get medications that directly addressed their liver damage. The FDA’s Office of Immunology and Inflammation’s acting director, Dr. Nikolay Nikolov, said this.

Nokolov stated in the FDA statement that Rezdiffra’s approval will, for the first time, provide these patients with a treatment option other than diet and exercise.

The liver is a vital organ responsible for cleansing the blood and secreting bile, which aids digestion. It is important to note, however, that over the long term, inflammation caused by obesity, diabetes, and high blood pressure can lead to nonalcoholic liver disease. This results in fat accumulation in the liver, scarring, and dysfunction of the liver.

FDA information says Rezdiffra is a partial activator of the thyroid hormone receptor.

By activating this receptor in the liver, Rezdiffra reduces liver fat accumulation. Due to the fact that the drug addresses an unmet medical need, the drug was approved under an “accelerated” pathway by the agency.

As part of an ongoing 54-month clinical trial, Madrigal Pharmaceuticals developed Rezdiffra, which was approved after a year of data collection. According to that study, liver scarring levels improved compared to placebo-treated groups.

According to the FDA, between 24% and 36% of patients with NASH who received 100 milligrams of Rezdiffra saw their NASH resolve and no worsening of their liver scarring, compared with 9% to 13% of patients with placebo, based on the assessments of various pathologists who examined patients’ liver scarring. There was a similar percentage of individuals who experienced a continuation of their NASH without liver scarring worsening, according to the agency.

The fact that these results were achieved within one year is noteworthy, given that “the disease generally progresses slowly, with most patients taking years or even decades before showing signs of improvement.”

Rezdiffra side effects includes diarrhea and nausea, and its label includes warnings regarding the potential risk of drug-induced liver damage and gallbladder problems.

Those with cirrhosis that has progressed beyond the decompensated stage should not take Rezdiffra, according to the FDA. The drug may interact with cholesterol-lowering statins, so a patient should discuss Rezdiffra with their physician.

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