European Health Regulators Agree To Use Of AI In Faty Heart Disease Trials

Illustration of one of the European Medicines Agency clinical trial activities (photo: x EMA_News)

JAKARTA The Human Medicine Committee (CHMP) of the European Medicines Agency (EMA) has approved the use of AIM-NASH artificial intelligence tools (AI) in clinical trials to help identify the severity of fatty liver disease.

This disease, known as metabolic dysfunction-assocized steatohepatitis (MASH), is a difficult condition to treat and is estimated to affect about 1.5% to 6.5% of adults in the United States. This is as reported by the American Liver Foundation.

AIM-NASH is an AI-based tool that uses a machine learning model that has been trained with more than 100,000 annotations from 59 pathologists. This data comes from more than 5,000 liver biopsys in nine major clinical trials.

CHMP states that available evidence suggests this AI can assess the disease activity of biopsies with less variation than the current standard, which still relies on the consensus of three pathologists. With this recognition, the AIM-NASH tool can be used to produce valid scientific evidence, thus assisting research in quantifying the effectiveness of new treatments for the disease.

Currently, the only drug approved in the United States to treat MASH is the Rezdiffra of Madrigal Pharmaceuticals. Meanwhile, major pharmaceutical companies such as Novo Nordisk and Elichalo are also testing their use of GLP-1 therapy to treat this fatty liver disease.