Madrigal Pharmaceuticals announces EMA validation of its MAA for resmetirom

Madrigal Pharmaceuticals announced that the Company’s Marketing Authorization Application, MAA, for resmetirom for the treatment of NASH/metabolic dysfunction-associated steatohepatitis, MASH, with liver fibrosis has been validated and is now under evaluation with the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP. “NASH with fibrosis represents a serious burden for both patients and health systems. Without treatment, the disease can lead to cirrhosis, liver failure, liver cancer and premature death,” said Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal. “Based on the positive results from our Phase 3 MAESTRO trials, we believe resmetirom has the potential to become the first therapy for patients with NASH with liver fibrosis to receive approval in Europe.”