Madrigal said the drug will be available to U.S. patients in April. (representative)
Washington:
The U.S. Food and Drug Administration (FDA) on Thursday approved the first drug to treat patients with severe non-alcoholic fatty liver disease.
Madrigal Pharmaceuticals’ Rezdiffra was shown to improve liver scarring in a clinical trial involving hundreds of patients with non-alcoholic steatohepatitis (NASH), the most severe form of the disease caused by the accumulation of fat in the liver.
“Previously, NASH patients with significant liver scarring have had no drugs that directly address liver damage,” said the FDA’s Nikolay Nikolov. “Today’s approval of Rezdiffra will for the first time provide these patients with an alternative to diet. and treatment options beyond exercise.”
NASH affects approximately 6-8 million people in the United States and is often associated with other health problems such as high blood pressure, type 2 diabetes, obesity, and high blood lipid levels.
Symptoms include weakness, severe fatigue, yellowing of the skin or eyes, spider veins, and more. NASH progresses to cirrhosis (the latest form of scarring), which over time leads to liver failure, requiring a transplant.
Rezdiffra, whose molecule name is resmetirom, is an oral drug that targets the underlying cause of NASH.
In a trial of 966 people, liver biopsies taken at 12 months showed that a greater proportion of subjects who received Rezdiffra developed the disease compared with those who received a placebo. Relief is obtained or liver scarring is improved. The findings were published in February in the New England Journal of Medicine.
Side effects include diarrhea and nausea.
“Rezdiffra’s accelerated approval is the culmination of more than 15 years of research by our founder, Dr. Becky Taub, and a small research and development team, who have tackled one of the greatest challenges in drug development,” said Bill Sibold, CEO of Madrigal.
Lorraine Steele of the American Liver Foundation also praised the “groundbreaking” treatment.
Madrigal said the drug will be available to U.S. patients in April.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
