US FDA to review AI-based tool to predict drug-related liver damage

June 3 (Reuters) - The U.S. ‌FDA's Center ​for ​Drug Evaluation and Research said on Wednesday it has accepted a letter of intent for an ‌artificial intelligence-based drug development tool designed to help ⁠predict drug-induced liver injury.

Drug-induced liver damage is a major cause of ‌trial failures, and current methods ‌do not reliably predict human risk. The U.S. Food and Drug Administration said the tool could potentially help ​improve early safety assessments, reduce reliance on animal testing and support more informed decisions before human trials begin.

Here ⁠are some details:

• The tool, an AI-driven digital liver model, has been admitted ​to the agency's Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot programme.

• The model is ​designed to assess the risk of ‌liver toxicity in new small-molecule drugs by comparing their chemical structures with existing medicines that ⁠have known safety profiles.

• "New technologies are showing incredible promise in helping improve and streamline drug development, with the ultimate goal of ⁠enhancing patient care," said Michael Davis, CDER's acting director.

• The acceptance ​marks the first step in a multi-stage qualification process that would allow drugmakers to use the tool in regulatory submissions if approved.

• ‌The Drug Development Tool qualification programme works with developers to guide tools for a specific ‌use, and a letter of intent is the first submission ⁠stage used by the ‌FDA to determine whether ​a tool will be accepted into the programme.

(Reporting by Siddhi Mahatole in Bengaluru; Editing by Diti ‌Pujara)

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