HESI COMMITTEE ON BIOMARKERS OF NEPHROTOXICITY
FDA and EMA Approve Novel Kidney Damage Biomarkers Characterized by HESI Committee
November 2010. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have issued final approval for use of two novel urinary renal safety biomarkers (Renal Papillary Antigen-1 and Clusterin) evaluated in a HESI collaborative experimental program. This program used a multi-laboratory approach to assess the reproducibility and specificity of these markers of non-clinical drug-induced kidney injury. In the case of RPA-1, the HESI study provided the first ever biological qualification data on this marker submitted to FDA or EMA. Both markers are now approved for use in evaluating site specific kidney injury in rats. According to Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research, the HESI submission “reflects a pioneering effort to find better evaluative tools to modernize the medical product development pathway.” Copies of the complete FDA and EMA reports are available via the HESI website. The HESI Committee on Biomarkers of Nephrotoxicity is currently continuing with efforts to further characterize the biological characteristics of these and other markers of kidney injury.
Please click here to access a copy of the FDA Biomarker Qualification Decision.
Please click here to access a copy of the EMA Qualification Opinion.
For more information on the program, please contact Syril Pettit at firstname.lastname@example.org