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BRIDGEWATER, N.J. and
Jan. 8, 2013 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) and its wholly owned subsidiary, Savient Pharma Ireland Ltd., today announced that the European Commission has granted a marketing authorization for KRYSTEXXA
® (pegloticase) for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.
"There is currently no other treatment option in the EU for patients with severe chronic tophaceous gout who do not respond to oral xanthine oxidase inhibitors," said Dr.
Thomas Bardin, MD, Professor and Head of the Rheumatology department at the Lariboisière Hospital in
Paris, France. "KRYSTEXXA addresses a significant unmet medical need and represents an important development for healthcare professionals and European patients suffering from this debilitating disease."
"European approval of KRYSTEXXA demonstrates our ongoing commitment to this underserved population by offering a much needed treatment option to these patients and marks a significant milestone for the Company," said
Lou Ferrari, President and Chief Executive Officer of Savient. "We continue to establish relationships with clinicians and key opinion leaders in
Europe, and we anticipate product launch in the region by mid-2013."
The European Commission's approval decision was based upon safety and efficacy data from Savient's two pivotal Phase III studies, and a long-term open label extension study of KRYSTEXXA, as well as non-clinical and chemistry, manufacturing and control information.
Until the product becomes commercially available in the EU, Savient will continue to provide KRYSTEXXA to patients through the established Named Patient Programme (NPP).