First drug for severe non-alcoholic fatty liver disease approved in the US

NEW DELHI: The first drug for patients with a severe form of non-alcoholic fatty liver disease was authorized by the US Food and Drug Administration (FDA) on Thursday. The drug Rezdiffra, manufactured by Madrigal Pharmaceuticals, has been shown in a clinical study to lessen liver scarring in hundreds of patients with non-alcoholic steatohepatitis (NASH), the most severe kind of liver-fat-causing illness.

According to the FDA’s Nikolay Nikolov, “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage.” “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise,” he said.
Six to eight million Americans suffer from NASH, which is associated with conditions including obesity, type 2 diabetes, and high blood pressure. Weakness, exhaustion, skin yellowing, spider-like blood vessels, and other symptoms are among them. NASH may cause cirrhosis, which can result in liver failure necessitating a liver transplant.
The oral medication rezdiffra, also known as resmetirom, works on the underlying causes of NASH. In comparison to the placebo group, a larger number of people treated with Rezdiffra had resolution or improvement in liver scarring, according to a 966-person study. Symptoms like nausea and diarrhea are typical.
Bill Sibold, the CEO of Madrigal, emphasized the “accelerated approval” after 15 years of study, while the the American Liver Foundation’s Lorraine Stiehl commended the therapy. “The accelerated approval of Rezdiffra is the culmination of more than 15 years of research from our founder,, Dr. Becky Taub,, and a small R&D team that took on one of the biggest challenges in drug development,” he said.
Patients in the US should get access to the medication in April.