EU approves AI tool for fatty liver disease trials

The European Medicines Agency (EMA) has approved an artificial intelligence tool called AIM-NASH for use in clinical trials. This AI tool helps in identifying the severity of a type of fatty liver disease known as metabolic dysfunction-associated steatohepatitis, or MASH. MASH is a challenging condition that affects approximately 1.5% to 6.5% of adults in the U.S., according to the American Liver Foundation. The AIM-NASH tool uses a machine learning model that has been trained on data from over 100,000 annotations made by 59 pathologists. These assessments were based on more than 5,000 liver biopsies collected during nine large clinical trials. The EMA's human medicines committee (CHMP) noted that AIM-NASH can determine disease activity from biopsies more reliably than the current standard method, which involves a consensus from three pathologists. This means the evidence from the AI tool can be considered scientifically valid, potentially leading to clearer results on new treatments in clinical trials. As of now, Madrigal Pharmaceuticals' drug, Rezdiffra, is the only treatment approved in the U.S. for MASH. Other companies, like Novo Nordisk and Eli Lilly, are also testing their own treatments for this liver disease.