AI tool AIM-NASH approved to help identify severity of fatty liver disease
The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) announced Thursday that it has approved the AI tool AIM-NASH in clinical studies to help identify the severity of a type of fatty liver disease called metabolic-associated steatohepatitis (MASH).
MASH is a difficult-to-treat disease that affects an estimated 1.5 to 6.5 percent of adults in the United States, according to the American Liver Foundation.
The AI-based tool AIM-NASH uses a machine learning model trained on more than 100,000 notes from 59 pathologists who evaluated more than 5,000 liver biopsies in nine large clinical studies.
The evidence shows that the AI tool can reliably determine the severity of MASH from biopsies with less variability than the current standard in studies that rely on consensus between three pathologists.
Currently, Madrigal Pharmaceuticals’ Rezdiffra is the only drug approved in the United States for MASH.
