FDA Accepts Letter of Intent to Qualify LSM by VCTE (FibroScan®) as First Non-Invasive Surrogate Endpoint in MASH Clinical Trials

FDA Accepts Letter of Intent to Qualify LSM by VCTE (FibroScan®) as First Non-Invasive Surrogate Endpoint in MASH Clinical Trials

This milestone opens a path for FibroScan® to ultimately replace liver biopsy for patient enrollment and treatment response assessment in MASH drug development WESTBOROUGH, Mass., Sept. 8, 2025 /PRNewswire/ — Echosens, the leader in non-invasive liver diagnostics, is announcing today that the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), […]

FDA acceptance of VCTE as trial endpoint can accelerate MASH drug development: GlobalData - Express Pharma

Following the news that the US FDA has accepted Echosens’ letter of intent to qualify liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) as a reasonably likely surrogate endpoint for metabolic dysfunction-associated steatohepatitis (MASH) trials with moderate-to-advanced fibrosis; Jay Patel, Senior Pharma Analyst at GlobalData, a leading data and analytics company, comments,“The announcement can have a transf…