EMA’s human medicines committee (CHMP) has issued the first Qualification Opinion (QO) on an innovative development methodology based on artificial intelligence (AI). The tool, called AIM-NASH, helps pathologists analyse liver biopsy scans to identify the severity of MASH (metabolic dysfunction associated steatohepatitis; formerly known as non-alcoholic steatohepatitis NASH) in clinical trials.
MASH is a condition where fat builds up in the liver, causing inflammation, irritation and scarring over time, without significant alcohol use or other reasons for liver injury. MASH is linked to obesity, type 2 diabetes, high blood pressure, abnormal cholesterol, and belly fat. If untreated, it can lead to advanced liver disease.
The AIM-NASH tool is expected to enhance the reliability and efficiency of clinical trials for new MASH treatments by reducing variability in measuring disease activity (inflammation and fibrosis)…
