Resmetirom for treatment of MASH

Abstract

Resmetirom (Rezdiffra), developed by Madrigal Pharmaceuticals, was granted Breakthrough Therapy designation, Fast Track designation, and Priority Review designation for the treatment of patients with MASH fibrosis by the US FDA on 14 March. Metabolic dysfunction-associated steatotic liver disease (MASLD) affects almost 30% of the adult population worldwide.1,2 For decades, therapeutic options were limited to addressing associated risk factors likeharmful alcohol use and metabolic risk3 and maintaining a healthy diet and lifestyle. Guidelines on the management of MASLD also recommend drugs approved to treat associated comorbidities, such as obesity and type 2 diabetes, with the potential to offer benefits in MASLD.The conditional approval of a metabolic dysfunction-associated steatohepatitis (MASH) drug has major impact on the treatment of patients and the prevention of serious complications and comorbidities. Definite approval is pending based on sustainability of histological benefits and long-term safety that are currently not available.