US Approves First Drug For People With Severe Form Of Fatty Liver Disease
The FDA has authorized Madrigal Pharmaceuticals' Rezdiffra, the first medication for severe non-alcoholic steatohepatitis (NASH), a progressive fatty liver disease.
Demonstrated to lessen liver scarring in clinical trials, Rezdiffra offers a novel treatment option beyond diet and exercise for patients with significant liver damage.
NASH, affecting an estimated 6-8 million Americans, can lead to symptoms like fatigue, jaundice, and ultimately liver failure, requiring a transplant if it becomes cirrhotic.
Resmetirom, the drug's active ingredient, is taken orally and combats NASH's root causes. In a study of 966 participants, it showed better outcomes than a placebo, with results published in the New England Journal of Medicine in February.
Despite side effects like diarrhea and nausea, both the American Liver Foundation and Madrigal's CEO have praised the approval of Rezdiffra, which is expected to be available in the US by April.