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Japanese Regulators Accept Critical Path's Biomarkers for Drug Toxicity Tests

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The Critical Path Institute today said that the Japanese Pharmaceuticals and Medical Devices Agency has accepted its seven-biomarker panel for use in detecting drug-induced kidney injury.

The acceptance, the first ever regulatory biomarker qualification decision by PMDA, means data generated using the panel can be submitted to the agency as part of the drug approval process in Japan, Critical Path said in a statement.

The biomarkers were developed by the Predictive Safety Testing Consortium, an initiative led by the Critical Path Institute that kicked off in 2006.

PMDA's decision follows similar ones by the US Food and Drug Administration and the European Medicines Agency in 2008.

The seven biomarkers are KIM-1, albumin, total protein, ß2-microglobulin; cystatin C, clusterin, and trefoil factor-3. According to Critical Path, PMDA decided that the panel can provide additional information for detecting drug-induced kidney injury in preclinical rat safety studies when used along with current standard biomarkers, serum creatinine and blood-urea nitrogen. Six of the biomarkers, by themselves, also perform better than the standard biomarkers, Critical Path said.

PMDA also said that the novel biomarkers in early clinical trials in Japan and elsewhere "may be accepted on a case-by-case basis in order to gather further data that PMDA considers necessary to qualify their usefulness in monitoring drug-induced renal toxicity" in humans.

The biomarker panel is the first approved by PMDA for drug-approval consideration under Japan's new special consultation process on pharmacogenomics/biomarkers, the institute added.

The Predictive Safety Testing Consortium submitted the panel to PMDA in August 2009, and the decision by the Japanese agency was rendered last month. The submission to PMDA included data from Novartis and Merck, who are members of PSTC, and researchers from Harvard Medical School and the FDA's research laboratories.

Critical Path said that PSTC and the FDA confirmed that since FDA and EMA rendered their decision two years ago, "several" sponsors successfully used the seven biomarkers to support decisions to either advance or terminate new-drug development programs.

"FDA, EMA, and PMDA's commitment to evaluate safety biomarker data submissions from PSTC demonstrates global recognition of the importance of new pathways for advancing regulatory science," said Predictive Safety Testing Consortium Director Elizabeth Gribble Walker.