Director’s statement on the first drug approved to treat MASH

Statement by Arun Sanyal, M.D., director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University, on the FDA approval of resmetirom to treat metabolic dysfunction-associated steatohepatitis (MASH):

“This is a major milestone for our patients and for the field. MASH is a leading cause of liver-related morbidity and mortality. With approved resmetirom, our patients with clinically significant scarring of the liver due to MASH will have access to an effective and approved therapeutic agent to reverse disease progression. As an investigator working on MASH, I congratulate Madrigal Pharmaceuticals and the communities of scientists and patients who participated in the treatment trials to make approved therapy for MASH a reality.”

Dr. Sanyal is an investigator in the Phase 3 program for resmetirom and a key leader whose broader contributions to the field helped establish the pathway to the first approved medication for NASH. Publications co-authored by Dr. Sanyal on resmetirom’s clinical testing:

• A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis
• Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis