Madrigal Pharmaceuticals Announces U.S. Availability of Rezdiffra (resmetirom) for the Treatment of Patients with Noncirrhotic NASH with Moderate to Advanced Liver Fibrosis

• Rezdiffra is the first and only medication approved by the FDA for the treatment of NASH (also known as “MASH”)
• First patients have received Rezdiffra via Madrigal’s specialty pharmacy network

CONSHOHOCKEN, Pa., April 09, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that Rezdiffra (resmetirom) is now available in the U.S. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

Bill Sibold, Chief Executive Officer of Madrigal, stated, “The introduction of Rezdiffra as the first and only FDA-approved therapy in NASH marks a turning point for Madrigal and the NASH community. Since approval, we have been partnering with healthcare providers, payers, and patient advocates to build new care pathways that will help patients access Rezdiffra and achieve their treatment goals. Our field teams are fully deployed, our specialty pharmacy network is processing prescriptions, our supply chain is fully operational, and most importantly, the first patients are now receiving Rezdiffra.”

Donna R. Cryer, JD, founder and Chief Executive Officer of the Global Liver Institute, stated, “Years of advocacy from the NASH community helped pave the way for Rezdiffra as the first approved medication for this long-neglected disease. We were thrilled to see that the Rezdiffra prescribing information is patient-centric: there is no biopsy requirement for diagnosis. Moving the field away from biopsy has been a long-time goal for the Global Liver Institute and I believe the availability of Rezdiffra will help grow patient awareness of noninvasive testing options for NASH.”

Naim Alkhouri, MD, FAASLD, Chief Medical Officer, Chief of Transplant Hepatology, Director of the Fatty Liver Program, Arizona Liver Health, stated, “The introduction of Rezdiffra is completely changing the conversation about NASH in our practice. I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH. Our team at Arizona Liver Health has never felt more energized, and we recently celebrated when our first patient received Rezdiffra.”