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FDA Accepts Proposal for Reasonably Likely Surrogate Endpoint for ‘MASH’ All-Cause Mortality or Liver-Related Events

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research, Office of New Drugs has accepted a Letter of Intent for the qualification of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography as a reasonably likely surrogate endpoint for clinical trials in adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis (scarring).

According to the Letter of Intent, the biomarker can predict risk of all-cause mortality or liver-related events in patients with MASH. MASH is a severe form of metabolic-associated fatty liver disease that develops when fat buildup in the liver causes inflammation and scarring. MASH is a progressive disease that can lead to cirrhosis (severe liver scarring), hepatic decompensation (worsening of liver function), liver cancer, liver transplantation, or death.

The proposed biomarker offers a non-invasive method for assessing liver stiffness; correlates with liver fibrosis severity; may predict clinical outcomes; and may provide a safer, more accessible approach for monitoring disease progression and treatment response.

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