FDA Approves Rezdiffra for Noncirrhotic NASH with Liver Fibrosis

Photo:Representative Image

Madrigal Pharmaceuticals, Inc., a biopharmaceutical company specializing in developing novel therapeutics for NASH, has announced that the US Food and Drug Administration (FDA) has granted accelerated approval for Rezdiffra (resmethrin) in combination with diet and exercise for the treatment of adults with non-cirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). The approval is subject to verification and description of clinical benefits in ongoing confirmatory trials.

Bill Sibold, CEO of Madrigal, stated that NASH with moderate to advanced liver fibrosis is a severe and progressive liver disease that has lacked FDA-approved therapy until now. 

The accelerated approval of Rezdiffra is the result of over 15 years of research by Dr. Becky Taub, Madrigal's founder, and her small R&D team, who took on one of the most significant challenges in drug development. This moment is historic for the NASH field and reflects what the industry can achieve. Madrigal is excited to provide Rezdiffra to patients in need.

Dr. Becky Taub, the founder, Chief Medical Officer, and President of Research & Development at Madrigal, expressed gratitude to the many patients who made the accelerated approval of Rezdiffra possible by participating in clinical studies.

 She believes that the drug will revolutionize the treatment paradigm for NASH with moderate to advanced liver fibrosis by providing physicians with a liver-directed therapy that can improve fibrosis and resolve NASH before their patients progress to cirrhosis.