Industry Review of Best Practices for Risk Management of Drug-Induced Liver Injury from Development to Real-World Use

Loreta Marquez (), Ritu Raheja, May Chan-Liston, John Marcinak, Alvin Estilo, Liliam Pineda Salgado, Jason Jiang, Curtis Chang and Paul Beninger ()
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Loreta Marquez: Janssen Research and Development, LLC
Ritu Raheja: AbbVie
May Chan-Liston: Bristol Myers Squibb
John Marcinak: AbbVie
Alvin Estilo: Otsuka Pharmaceutical Development, Inc. (OPDC)
Liliam Pineda Salgado: Otsuka Pharmaceutical Development, Inc. (OPDC)
Jason Jiang: Daiichi Sankyo, Inc.
Curtis Chang: Takeda
Paul Beninger: Tufts University School of Medicine

Drug Safety, 2024, vol. 47, issue 1, No 1, 22 pages

Abstract: Abstract The relative treatment benefit of a drug for patients during development, marketing authorization review, or after approval includes an assessment of the risk of drug-induced liver injury (DILI). In this article, the Pharmacovigilance and Risk Mitigation Working Group of the IQ-DILI Initiative launched in June 2016 within the International Consortium for Innovation and Quality in Pharmaceutical Development presents and reviews three key topics for essential risk management activities to identify, characterize, monitor, mitigate, and communicate DILI risk associated with small molecules during drug development. The three topics are: (1) Current best practices for characterizing the DILI phenotype and the severity and incidence of DILI in the treatment population, including DILI identification, prediction and recovery. (2) Characterization of the relative treatment benefit for patients who will be exposed to a drug and the attendant risk of DILI in conjunction with existing global risk mitigation strategies. (3) Implementation of risk mitigation strategies during drug development highlighting patient factors, healthcare settings and site of product administration, and prescriber and healthcare provider factors. Industry guidance is provided for assessing whether the product labeling is sufficient to minimize the risk of DILI or whether a United States Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) or European Medicines Agency (EMA) Risk Management Plan (RMP) with additional Risk Minimization Measures (aRMM) is needed.

Date: 2024
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DOI: 10.1007/s40264-023-01360-x

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