Updated on 9 January 2015
Pyridorin has been accepted by USFDA
Singapore: NephroGenex, pharmaceutical company focused on the development of therapeutics to treat kidney disease, has received positive scientific advice from the European Medicines Agency (EMA) regarding its phase 3 program for Pyridorin in diabetic nephropathy.
Pyridorin has been accepted by the US Food and Drug Administration under a Special Protocol Assessment.
The EMA indicated that Phase 3 program of the drug trial could be adequate to support a marketing authorization application for full market approval in Europe.
"The EMA's support of our pivotal Phase 3 trial in Pyridorin strengthens our global regulatory strategy for this important clinical program," said Mr Pierre Legault, CEO, NephroGenex. "Diabetic nephropathy is a growing problem around the world, and Pyridorin has the potential to improve the care of the millions of patients who suffer from diabetic kidney disease and have few therapeutic options."
Diabetic nephropathy is a chronic, degenerative disease of the kidney caused by diabetes. Pyridorin inhibits pathogenic oxidative chemistries, which are collectively elevated in diabetic patients and induce pathological changes implicated in the development of diabetic nephropathy.