- The FDA has approved Madrigal Pharmaceuticals’ resmetirom, sold under the brand name Rezdiffra, as the first therapy for MASH, also known as nonalcoholic steatohepatitis (NASH), specifically for patients with moderate or severe liver scarring (stage F2 and F3 disease).
- This approval marks a significant milestone in the treatment of MASH, a common liver disease, ending a decades-long wait for an effective treatment. Rezdiffra emerged successful from a field that has been challenging for drug development.
- The approval was based on the MAESTRO-NASH trial, which involved about 900 patients with biopsy-confirmed MASH and liver fibrosis. Rezdiffra showed effectiveness in clearing MASH with no worsening of fibrosis in a significant percentage of patients compared to placebo.
- The recommended dosage of Rezdiffra varies based on body weight, with 80mg for those weighing less than 100kg and 100mg for others.
FDA approves first MASH drug: Madrigal’s Rezdiffra breaks ground in notorious biopharma graveyard (Fierce Healthcare)
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