FDA and EMEA collaboration expected to yield additional safety data

In the first use of a framework allowing submission of a single application to the two agencies, the US Food and Drug Administration and the European Medicines Agency (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins, or biomarkers, found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity, the FDA notes in a press statement.

The new biomarkers are KIM-1, Albumin, Total Protein, b2-microglobulin, Cystatin C, Clusterin and Trefoil Factor-3. For decades, both the FDA and EMEA have required drug companies to submit the results of two blood tests, called blood urea nitrogen and serum creatinine, to evaluate renal toxicity. In addition to those tests, the two regulatory agencies will now consider results from the seven new tests as part of their respective drug review processes. Although a decision by the sponsor to collect information using the new tests is voluntary, if this is done, it must be submitted to the FDA.

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