Saving kidneys
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Saving kidneys The EMEA and the US FDA will accept data generated by a new method for predicting the renal toxicity of investigational drugs.1 The method involves measurement of key biomarkers in urine during animal testing that can provide additional information about potential renal toxicity.
Seven new signals Testing for toxicity in animals is conducted prior to commencing human clinical trials of a new drug. However, animal toxicity results are not always the best predictor of drug safety in humans, thus the search for new measures of safety. In a collaborative effort, the EMEA and FDA will now consider results from seven new biomarker tests as part of their respective review processes, in addition to the two mandatory blood tests – blood urea nitrogen and serum creatinine. 1 While the decision to use the new tests is voluntary, if collected the sponsor must submit the results. The seven biomarkers are KIM-1, albumin, total protein, β2-microglobulin, urinary cystatin C, urinary clusterin and urinary trefoil factor 3.1,2 These biomarkers, which will initially be used in preclinical animal studies, were selected as identical biomarkers are produced in human kidney cells1 and are considered acceptable for detection of acute drug-induced nephrotoxicity.2 The development of these biomarkers was driven by the Predictive Safety Testing consortium, organised by the nonprofit Critical Path Institute. The consortium is working on qualifying the biomarkers for use in human trials and, if successful, will submit a new application to both agencies seeking acceptance of the human biomarkers. The ultimate goal would be development of a range of biomarkers to signal serious adverse effects such as cardiotoxicity, hepatotoxicity or carcinogenicity.
Future hope Director of the FDA’s Center for Drug Evaluation and Research Dr Janet Woodcock expressed her hope that these biomarkers might lead to human tests that could detect drug-induced kidney injury earlier than is currently possible.1 She added that such tests might lead to the approval of "more powerful drugs" – especially for diseases were renal toxicity prevents promising investigational drugs from being approved. "With more sensitive tests for renal toxicity, FDA could approve such drugs because health care professionals could closely monitor patients and halt the drug if early signs of renal toxicity appear," she explained. The co-ordinated decision by the two agencies is a first. They have developed a framework allowing submission of a single application to both regulators. The EMEA has published a draft guidance document on biomarkers qualification, which is available for public consultation until end-June 2008.3 1. FDA. FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety. Media Release : 12 Jun 2008. Available from: URL: http://www.fda.gov. 2. Final report on the pilot joint EMEA/FDA VXDS experience on qualification of nephrotoxicity biomarkers. Internet Document : [1 page], 23 May 2008. Available from: URL: http://www.
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