FDA accepts proposal for reasonably likely surrogate endpoint for ‘MASH’ all-cause mortality or liver-related events

https://www.fda.gov/drugs/drug-safety-and-availability/fda-accepts-proposal-reasonably-likely-surrogate-endpoint-mash-all-cause-mortality-or-liver-related?utm_medium=email&utm_source=govdelivery 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.