FDA Approves Resmetirom for MASH

Resmetirom received accelerated FDA approval in March 2024 for treating metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced fibrosis (F2-F3), based on positive outcomes from the MAESTRO-NASH and MAESTRO-NAFLD-1 trials.

Recommending Non-invasive Liver Disease Assessments

Chronic liver disease (CLD) causes approximately two million deaths annually and presents a major global health burden. Because most severe outcomes—like liver failure, portal hypertension, and hepatocellular carcinoma—occur in those with advanced fibrosis, early detection is essential.

Liver Biopsy Evaluation in MASH

During recent decades, the metabolic dysfunction-associated steatohepatitis (MASH) field has witnessed several paradigm shifts, including the recognition of liver fibrosis as the main predictor of major adverse liver outcomes.

Advancements in MASLD Diagnosis: Non-Invasive Tools

Medications stacked on a pharmacy counter, ready to be sold. Represents a typical scene in the daily routine of a pharmacy

Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as NASH, is a growing health concern due to its association with metabolic dysfunction, including insulin resistance, oxidative stress, and mitochondrial dysfunction.

GLP-1 Agonists’ Potential for Fibrosis Regression

In a recent review, researchers examined the molecular and clinical effects of glucagon-like peptide 1 (GLP-1) receptor agonists in treating metabolic dysfunction-associated steatotic liver disease (SLD).

Resmetirom and Advanced Liver Fibrosis

Resmetirom (MGL-3196) received accelerated FDA approval in March 2024 for treating MASH with moderate to advanced liver fibrosis (F2-F3). This approval followed the MAESTRO-NASH trial, which showed significant efficacy in resolving MASH and improving fibrosis without worsening steatohepatitis.

Resmetirom FDA-Approved for MASH

In 2024, resmetirom (MGL-3196) became the first FDA-approved drug for MASH, demonstrating significant efficacy in resolving MASH without worsening fibrosis in 27% of patients, compared to 10% in the placebo group.

MASLD: The Growing Need for Early Intervention

MASLD (metabolic-associated steatotic liver disease) is the most common chronic liver disease in the US, affecting an estimated 31% of adults. A recent study showed that 38% of middle-aged Americans had MASLD, with 14% diagnosed with MASH and 5.9% exhibiting significant fibrosis (F2/3).