EAST BRUNSWICK, N.J., March 15 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. today announced that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs 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.
"We believe that this resubmission combined with the submissions made and planned by our third party contract manufacturer fully addresses the deficiencies and observations raised and provides the additional materials requested in the Complete Response Letter that we received from the FDA on July 31, 2009, which were further clarified in our meeting with the FDA on September 14, 2009," stated Paul Hamelin, President of Savient. "We look forward to the advancement of this novel biologic through the regulatory review process including the potential reinspection of our contract manufacturer in the months ahead. We continue to believe that Krystexxa has the potential to fill a void in an area of significant unmet medical need and are confident that this is a quality resubmission package that can support a favorable determination by the FDA."
ABOUT SAVIENT PHARMACEUTICALS, INC.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing KRYSTEXXA(TM) (pegloticase) for the treatment of chronic gout in patients refractory to conventional therapy. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA, formerly referred to as Puricase(R), from Duke University and Mountain View Pharmaceuticals, Inc. Savient also manufactures and supplies Oxandrin(R) (oxandrolone tablets, USP) CIII in the U.S. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.
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Savient Pharmaceuticals, Inc.
