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New Data Published in Annals of the Rheumatic Diseases Confirm Long-Term Safety and Efficacy of KRYSTEXXA® for the Treatment of Refractory Chronic Gout


Savient Pharmaceuticals (NASDAQ: SVNT) today announced that new data from an open-label extension (OLE) study published in the Annals of the Rheumatic Diseases reinforced the safety and efficacy profile of KRYSTEXXA^® (pegloticase) treatment for refractory chronic gout (RCG) over the long-term. OLE data aligned with outcomes seen in the KRYSTEXXA pivotal Phase III clinical trials, with no new safety signals identified. Improvements in clinical status were sustained or advanced during and up to two and a half years of additional treatment as evidenced by flare and tophus reduction first initiated in KRYSTEXXA-treated Phase III trial participants who maintained goal range urate-lowering responses. In addition to publication in the international peer-reviewed journal, two posters further demonstrating the safety and efficacy seen in the OLE study will be presented this week at the American College of Rheumatology/Associate Rheumatology Health Professional (ACR/AHRP) Annual Meeting, November 9-14, 2012.

"These data are encouraging because they confirm the long-term safety of KRYSTEXXA as well as a durable and progressive response to treatment," said Michael A. Becker, M.D., principal investigator, Professor Emeritus of Medicine, University of Chicago. "This is great news for those patients who have refractory chronic gout, or RCG, since treatment options are limited for this severe, debilitating and progressive form of gout." 

The study enrolled 151 patients who completed one of the two Phase III randomized, double-blind, placebo-controlled registration trials. Patients received either 8 mg KRYSTEXXA every two weeks, or the same dose every four weeks, for the management of RCG. Consistent with Phase III trials, gout flares and injection reactions were the most frequently reported adverse events (71 percent and 44 percent of patients, respectively), and they were least common in patients with a sustained response to KRYSTEXXA and those receiving treatment every two weeks. In most patients defined as KRYSTEXXA responders in the Phase III trials, plasma and serum uric acid levels remained less than 6 mg/dL, and sustained and progressive improvements in tophus resolution and flare incidence were seen throughout the study period.

Posted-In: News FDA


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