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Savient
Pharmaceuticals, Inc.
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).
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