The Food and Drug Administration (FDA) has greenlighted the accelerated evaluation of Madrigal Pharmaceuticals’ novel medication, resmetirom, designed to combat nonalcoholic steatohepatitis (NASH) in adults with liver fibrosis. This pivotal decision marks the assignment of a Prescription Drug User Fee Act (PDUFA) date set for March 14, 2024, spotlighting the urgency to address the escalating NASH crisis in the United States.
Understanding NASH: A Growing Health Concern
Nonalcoholic steatohepatitis, a critical progression of nonalcoholic fatty liver disease (NAFLD), is currently affecting an estimated 30% of the adult population in the US. The condition has emerged as a contributor to liver-related diseases, particularly among individuals presenting advanced metabolic risk factors such as hypertension and type 2 diabetes.
Resmetirom: A Revolutionary Oral Treatment
In the backdrop of the alarming increase in NASH cases, resmetirom emerges as a beacon of hope. This daily oral medication functions as a thyroid hormone receptor (THR)-β selective agonist. Its mechanism targets the compromised thyroid hormone beta activity in the liver, a hallmark of NASH. By enhancing mitochondrial function and fostering the beta-oxidation of fatty acids, resmetirom aims to curb inflammation and liver fibrosis, offering a potential lifeline to those battling this debilitating disease.
