Critical Path Institute announce EMA support for hepatocellular biomarker

The Critical Path Institute (AZ, USA) received a letter of support from the European Medicines Agency (EMA; London, UK) to encourage the future study of the measurement of glutamate dehydrogenase as a biomarker for hepatocellular liver injury. The letter was received in response to research data submitted by the Critical Path Institute Predictive Safety Testing Consortium and Duchenne Regulatory Science Consortium.

The supporting letter details EMA’s encouragement for the generation of additional clinical safety data and for further clinical studies to enable the formal qualification of glutamate dehydrogenase as a biomarker in the future. The letter encourages the use of this biomarker in nonclinical and clinical studies, indicating the potential for use in humans.

Jane Larkindale, Executive Director of the Duchenne Regulatory Science Consortium commented: “Many of the proteins currently monitored to evaluate liver safety are also found in muscle tissue. In situations where a patient has underlying muscle injury, such as muscular dystrophies, levels of these enzymes may be high in the absence of liver injury. Monitoring of GLDH levels may allow liver injury caused by novel drugs to be detected in this population of patients.”

Martha Brumfield, C-Path President and CEO, concluded: “The data package submitted to EMA supporting use of this liver-injury biomarker, developed by PSTC and D-RSC in partnership, exemplifies successful cross-consortium collaboration at C-Path, and EMA’s support of this biomarker is a harbinger of future success for both consortia. Developing reliable biomarkers remains one of the most productive methods of aligning and streamlining research and regulatory processes.”

Source: https://c-path.org/critical-path-institute-receives-regulatory-support-for-liver-injury-biomarker/