The European Medicines Agency (EMA) has endorsed the use of an artificial intelligence tool, AIM-NASH, in clinical trials to assess the severity of metabolic dysfunction-associated steatohepatitis (MASH), a challenging fatty liver disease.
The approval, granted by the EMA’s human medicines committee (CHMP) on Thursday, is expected to improve diagnostic accuracy in clinical research, reducing inconsistencies associated with human assessments. MASH affects an estimated 1.5% to 6.5% of adults in the United States, according to the American Liver Foundation.
AIM-NASH utilizes a machine learning model trained on more than 100,000 annotations from 59 pathologists who analyzed over 5,000 liver biopsies across nine major clinical trials. The CHMP determined that the AI tool offers a more consistent and reliable approach to evaluating disease activity compared to traditional methods, which rely on a consensus among three pathologists.
This scientific validation means evidence generated by the tool can now be accepted in clinical trials, potentially accelerating the development of new treatments.
The decision is a significant step forward in the fight against MASH, a disease that has proven difficult to treat. Currently, Madrigal Pharmaceuticals’ Rezdiffra is the only U.S.-approved medication for the condition. However, several pharmaceutical giants, including Novo Nordisk and Eli Lilly, are actively conducting trials using their GLP-1 treatments to explore new therapeutic options. The integration of AI in these trials could enhance precision and efficiency in evaluating drug efficacy.
With the EMA’s endorsement, AIM-NASH is set to play a crucial role in future clinical research, offering drugmakers a more standardized and data-driven method for assessing liver disease progression. The move reflects a broader shift towards AI-driven healthcare solutions, with experts anticipating that such innovations will continue to shape the future of medical research and treatment development.