Reata gets Euro orphan drug tag for kidney med candidate

Reata Pharmaceuticals announced that the European Commission, or EC, has granted orphan drug designation, based on the positive opinion from the Committee for Orphan Medicinal Products, or COMP, of the European Medicines Agency, or EMA, for bardoxolone methyl for the treatment of Alport syndrome. Alport syndrome is a rare, genetic form of chronic kidney disease, or CKD, caused by mutations in genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane in the kidney. A majority of patients with Alport syndrome develop CKD and many progress to end-stage renal disease. In the Phase 2 portion of the Phase 2/3 CARDINAL study, bardoxolone significantly increased patients’ estimated glomerular filtration rate after 36 weeks of treatment

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