EMA’s Newly Qualified AI Tool To Boost MASH Market Dynamics

The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.

An AI-based pathology tool could help bring new MASH drugs to patients faster (Shutterstock)
Key Takeaways
  • 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.
  • The European Medicines Agency’s qualification of the tool means that the agency can accept evidence generated by the tool as scientifically valid in future applications from drug companies.
  • A report by Datamonitor lists over 150 treatments for MASH in various phases of development.
  • AIM-NASH is the first AI-based development methodology to be qualified by the EMA.

AIM-NASH, the first artificial intelligence (AI)-based pathology tool to be qualified by the European Medicines Agency for assessing drug candidates for metabolic dysfunction-associated steatohepatitis (MASH), could boost the market dynamics...

While only one drug has been approved in the US for the condition, the MASH space is crowded with a robust pipeline of drug candidates chasing a potentially lucrative market...

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