Positive Phase III data for Krystexxa (Savient Pharma) in Gout patients with chronic Kidney Disease - 06-Jun-2012

New results show that patients with refractory chronic Gout (RCG) who also suffer from chronic Kidney Disease (CKD) responded to treatment with Krystexxa (pegloticase), from Savient Pharma, regardless of baseline CKD stage. This post-hoc analysis evaluated more than 200 patients with CKD stages one through four who were randomized to receive treatment with Krystexxa 8 mg every other week, 8 mg every four weeks or placebo. Baseline CKD stage was similar across treatment arms, and there was no significant difference in rates of response to Krystexxa by CKD stage (p<0.311). Additionally, treatment with Krystexxa did not impact estimated GFR levels in patients with or without CKD. Similar results were seen in a 24-month open-label extension study. Data were presented by Robert A. Yood, Principal Investigator, Clinical Professor of Medicine at the University of Massachusetts Medical School, at the European League Against Rheumatism Congress. Savient is seeking approval for Krystexxa in Europe and filed its Marketing Authorization Application with the EMA in May 2011.