The U.S Food and Drug Administration (FDA) and its European counterpart, the European Medicines Agency (EMEA) are for the first time jointly accepting submission of a single application to the two agencies. Drug companies are being allowed to submit results of seven recently developed tests evaluating kidney damage from new drugs. These tests measure seven protein biomarkers in urine that can indicate renal toxicity.

Previously, both the FDA and EMEA required drug companies to submit the results of blood urea nitrogen (BUN) and serum creatine for evaluations of toxicity. Now the agencies will additionally consider the biomarkers KIM-1, Albumin, Total Protein, B2-microglobulin, Cystatin C, Clusterin, and Trefoil Factor-3. Collection of the seven new biomarkers is voluntary, but if they are collected they must be submitted.

The biomarker development was led by the Predictive Safety Testing Consortium (PSTC), a group that includes pharmaceutical company scientists; the PSTC was organized by the Critical Path Institute, a nonprofit organization supporting FDA research collaborations for drug improvement.
This is the first project is involving a group of drug companies working together to propose and qualify new safety tests and then presenting them jointly to the FDA and EMEA for consideration. The FDA and EMEA enabled the joint biomarker reviews in 2004 under a framework called the Voluntary Exploratory Data Submission review process. This process allows the PSTC to submit an application to both regulatory agencies, and then to meet with both agencies to discuss additional questions. The FDA and EMEA then reviews the application separately and makes independent decisions on use of the new biomarkers.

Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research stated that such human tests could one day open the door to the approval of more powerful drugs, especially for diseases where renal toxicity currently prevents promising experimental 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.

FDA scientists believe that the seven new tests may have advantages over the BUN and creatinine tests in higher sensitivity: the tests apparently can detect cellular damage within hours. In addition, the new tests can pinpoint which parts of the kidney have been affected by the drugs.

The seven new tests will be carried out initially in rats, but the PSTC has begun work to further qualify the biomarkers for use in human studies. If successful, the PSTC will present a new biomarker data application to the two agencies to seek acceptance of the human biomarkers.

More information available at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01850.html
http://www.emea.europa.eu/#

More Industry Headlines