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# FDA Approves Madrigal Fatty Liver Drug
- URL: https://www.fdaweb.com/fda-approves-madrigal-fatty-liver-drug/
- Published: 2024-03-14T12:00:00.000Z
- Updated: 2026-09-14T14:25:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156563

FDA has approved a Madrigal Pharmaceuticals NDA for Rezdiffra (resmetirom) for treating adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis). “NASH is a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction,” an FDA [release says](https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease?ref=fdaweb.com). “NASH is often associated with other health problems such as high blood pressure and Type 2 diabetes.”

The product’s accelerated approval was based on an analysis of a surrogate endpoint at month 12 in a 54-month, randomized, double-blind placebo-controlled trial, the agency says. “The surrogate endpoint measured the extent of liver inflammation and scarring,” it says, adding that Madrigal is required to conduct a postapproval study to verify and describe Rezdiffra’s clinical benefit — the completion of the same 54-month study.

According to FDA, at 12 months liver biopsies “showed that a greater proportion of subjects who were treated with Rezdiffra achieved NASH resolution or an improvement in liver scarring as compared with those who received the placebo. A total of 26% to 27% of subjects who received 80 milligrams of Rezdiffra and 24% to 36% of subjects who received 100 milligrams of Rezdiffra experienced NASH resolution and no worsening of liver scarring, compared to 9% to 13% of those who received placebo and counseling on diet and exercise.”

Regarding safety, FDA says Rezdiffra’s most common side effects include diarrhea and nausea. Rezdiffra’s labeling also comes with certain warnings and precautions, such as drug-induced liver toxicity and gallbladder-related side effects.