FDA will Accept Kidney Toxicity Biomarkers in Drug Approval ProcessJun 13, 2008 | Parker Waichman LLP
The Food & Drug Administration (FDA) has decided to allow data for seven kidney toxicity biomarkers as part of the drug approval process. Both the FDA and the European Medicines Association (EMA) have agreed to accept the biomarker data, making it the first use of a framework allowing submission of a single application to the two agencies.
A biomarker is an indicator that can be used to test a biological function. Some biomarkers turn up when organs are injured and cells within the damaged tissue release substances into the blood, urine or saliva. These substances can be used to detect dangerous drug side effects. Ultimately, the pharmaceutical industry would like to see the FDA adopt a range of such biomarker tests for human clinical trials that would signal dangerous side effects like heart failure, liver damage or cancer.
Under current testing protocols, experimental drugs are subjected to animal testing before they can move on to human clinical trials. But animal tests aren’t always the best predictor of whether substances will be safe for humans. For example, if a drug toxic to the kidneys passes animal tests today, the damage might not show up until it is too late. Under a biomarker protocol, samples of blood, urine or saliva, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.
To date, both the FDA and EMEA have required drug companies to submit the results of two blood tests -- blood urea nitrogen and serum creatinine -- to evaluate renal toxicity. Now, in addition to those tests, the agencies will accept results from the seven biomarker-based tests as part of the drug-review process. The FDA and EMEA will now accept the results of tests that measure the levels of seven proteins found in urine that are indicative of drug-induced damage to kidney cells. Drug makers are not required to collect this biomarker data, but if they do, “it must be submitted to FDA,” the agency said.