The European Medicines Agency (EMA) has approved the use of an artificial intelligence (AI) tool, AIM-NASH, to assess the severity of metabolic dysfunction-associated steatohepatitis (MASH) in clinical trials. The condition, which affects 1.5% to 6.5% of U.S. adults, is a challenging liver disease with limited treatment options.
AIM-NASH utilizes machine learning trained on over 100,000 annotations from 59 pathologists who analyzed more than 5,000 liver biopsies across nine major clinical trials. The EMA’s human medicines committee (CHMP) found that the AI tool provides more consistent and reliable assessments than traditional methods, which rely on subjective evaluations from multiple pathologists.
With this approval, data generated using AIM-NASH will be considered scientifically valid in clinical trials, potentially accelerating the development of new MASH treatments. Currently, Madrigal Pharmaceuticals’ Rezdiffra is the only U.S.-approved drug for MASH, while companies like Novo Nordisk and Eli Lilly are conducting trials to explore additional treatment options.
