Resmetirom, the First Drug Approved by the U.S. FDA for Treating Patients with Nonalcoholic Steatohepatitis

On March 14, 2024, resmetirom (Rezdiffra) became the first drug approved by the U.S. FDA for treating patients with noncirrhotic nonalcoholic steatohepatitis (NASH; recently renamed metabolic dysfunction–associated steatohepatitis, or MASH) and moderate-to-advanced hepatic fibrosis.¹ This drug is an agonist of thyroid hormone receptor-β; agonists of this receptor in the liver promote hepatic fat metabolism and prevent hepatic injury resulting from lipotoxicity.

The pivotal manufacturer-sponsored randomized trial that led to FDA approval (MAESTRO-NASH) was reviewed recently in NEJM Journal Watch.² In brief, nearly 1000 patients with biopsy-proven NASH (fibrosis stages 2 or 3) received resmetirom or placebo, taken orally once daily; participan…