US FDA, EMEA to consider new biomarker data for drug safety assessments page 1

US FDA, EMEA to consider new biomarker data for drug safety assessments

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  • Inpharma 1643 - 21 Jun 2008

    Saving kidneysThe EMEA and the US FDA will accept data generated

    by a new method for predicting the renal toxicity ofinvestigational drugs.1 The method involvesmeasurement of key biomarkers in urine during animaltesting that can provide additional information aboutpotential renal toxicity. The co-ordinated decision by thetwo agencies is a first.

    Testing for toxicity in animals is conducted prior tocommencing human clinical trials of a new drug.However, animal toxicity results are not always the bestpredictor of drug safety in humans, thus the search ofnew measures of safety. In a collaborative effort, theEMEA and FDA will now consider results from sevennew biomarker tests as part of their respective reviewprocesses, in addition to the two mandatory blood tests blood urea nitrogen and serum creatinine.1. While thedecision to use the new tests is voluntary, if collectedthe sponsor must submit the results.

    Seven new signalsThe seven biomarkers are KIM-1, albumin, total

    protein, 2-microglobulin, urinary cystatin C, urinaryclusterin and urinary trefoil factor 3.1,2 These tests,which will initially be used in preclinical animal studies,were selected as identical biomarkers are produced inhuman kidney cells1 and are considered acceptable fordetection of acute drug-induced nephrotoxicity.2

    The development of these biomarkers was driven bythe Predictive Safety Testing consortium, organised bythe nonprofit Critical Path Institute. The consortium isworking on qualifying the biomarkers for use in humantrials and, if successful, will submit a new application toboth agencies seeking acceptance of the humanbiomarkers. The ultimate goal would be development ofa range of biomarkers to signal serious adverse effectssuch as cardiotoxicity, hepatotoxicity or carcinogenicity.1. FDA. FDA, European Medicines Agency to Consider Additional Test Results

    When Assessing New Drug Safety. Media Release : 12 Jun 2008. Availablefrom: URL:

    2. Final report on the pilot joint EMEA/FDA VXDS experience on qualification ofnephrotoxicity biomarkers. Internet Document : [1 page], 23 May 2008.Available from: URL:



    Inpharma 21 Jun 2008 No. 16431173-8324/10/1643-0001/$14.95 Adis 2010 Springer International Publishing AG. All rights reserved