We congratulate C-PATH (Critical Path Institute) on their success in getting the FDA to qualify a new biomarker– glutamate dehydrogenase (GLDH)– to monitor drug-induced liver injury in clinical trials.
This development is important in Duchenne and Becker because other biomarkers typically used to monitor liver injury (such as alanine aminotransferase, or ALT) can already be elevated in individuals with muscle injury, making interpretation of results more difficult. GLDH is a more specific marker of liver injury, and its inclusion in clinical trials in individuals with muscle injury represents an improvement in liver safety monitoring.
As a member and data contributor to C-PATH’s Duchenne Regulatory Science Consortium, we are so pleased to have been part of this important milestone.
Link to FDA decision: link to the announcement
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