Savient Pharmaceuticals, Inc. announced that the FDA has acknowledged receipt of and accepted for review the resubmission of the Biologics License Application (BLA) for Krystexxa (pegloticase), a treatment for chronic gout in patients refractory to conventional therapy. The FDA also acknowledged that the BLA resubmission contains additional chemistry, manufacturing and controls (CMC), Safety Update, Labeling, Risk Evaluation and Mitigation Strategy (REMS) and Medication Guide submitted in response to the FDA’s July 31, 2009 complete response letter.
Krystexxa is a PEGylated uricase enzyme. It is intended for use in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.
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