A 44-year-old man with MASLD (metabolic dysfunction-associated steatotic liver disease), T2DM, and obesity (BMI 34) is found to have liver biopsy-confirmed MASH (metabolic-associated steatohepatitis) with fibrosis stage F2. He asks about pharmacotherapy for liver disease per 2023–2024 FDA approvals. Which agent is the first FDA-approved drug specifically for MASH with fibrosis?
- A Obeticholic acid
- B Semaglutide
- C Resmetirom ✓
- D Pioglitazone
Correct answer: C. Resmetirom
Explanation
Resmetirom (Rezdiffra), a thyroid hormone receptor-beta selective agonist, received FDA approval in March 2024 as the first pharmacological agent specifically approved for MASH with moderate-to-advanced fibrosis (F2–F3), based on the MAESTRO-NASH phase 3 trial demonstrating MASH resolution and fibrosis improvement. Semaglutide and pioglitazone improve hepatic steatosis and inflammation but are not FDA-approved specifically for MASH. Obeticholic acid failed to gain full approval due to safety concerns.
Reference: Harrison's Principles of Internal Medicine, 21st ed.
High-yield for: NEET PGINI-CETNExTFMGEUSMLEPLABMRCP
Written and medically reviewed by the StethoPrep medical team.