(Reuters) -A committee of the European Medicines Agency, on Thursday, accepted the use of a tool for artificial intelligence (AI) called AIM -Nash in clinical tests to identify the severity of a kind of liver delivery disease.
The condition, metabolic dysfunction-associated steatohepatitis or puree, is a difficult to treat disease that, according to the American Last Foundation, affects approximately 1.5% to 6.5% of adults in the US.
The AI-based AIM-NASH tool uses a machine learning model that has been trained on more than 100,000 annotations of 59 pathologists who have assessed more than 5,000 liver biopsy during nine major clinical studies.
The EMA's Human Medicines Committee (CHMP) said that evidence showed that the AI tool can reliably determine the disease activity from biopsies with less variability than the current standard in tests dependent on a consensus of three pathologists.
Based on this, the CHMP concluded, the proof can accept that the tool has been generated as scientifically valid, which will help researchers get clearer evidence about the benefits of new treatments in clinical examinations.
Currently, Madrigal Pharmaceuticals', Rez Diffra is the only drug approved by the US for Mash.
Drug makers such as Novo Nordisk and Eli Lilly also conduct studies with their blockbuster GLP-1 treatments to treat patients with liver disease.
(Reporting by Christy Santhosh in Bengaluru; Edit by Savio D'Souza)
