EAST BRUNSWICK, N.J., May 26, 2011 /PRNewswire/ — Savient
Pharmaceuticals, Inc. (Nasdaq:
SVNT) today announced that the Marketing Authorization
Application (MAA), filed by its wholly owned subsidiary, Savient
Pharma Ireland Limited, seeking approval of KRYSTEXXA®
(pegloticase) for the treatment of chronic gout in adult patients
refractory to conventional therapy, has completed validation by the
European Medicines Agency (EMA). The MAA has been deemed
valid by the EMA which determination initiates the EMA’s regulatory
review process. The MAA includes safety and efficacy data
from Savient’s pivotal Phase 3 and long-term open label extension
studies of KRYSTEXXA, as well as detailed information on
non-clinical studies and chemistry, manufacturing and control of
production.
John H. Johnson, Chief Executive Officer of Savient, said, “We
are pleased to have achieved this important milestone in our
mission to bring relief to patients suffering from refractory
chronic gout in Europe. Currently there are no EMA approved
treatments for this condition available in the European Union,
which demonstrates the clear unmet need for new therapies to treat
patients suffering from this debilitating disease. We look forward
to working with the EMA to complete the review process.”
KRYSTEXXA became commercially available in the United States by
prescription on December 1, 2010, and is the only FDA approved
product specifically indicated for the treatment of chronic gout in
adult 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. KRYSTEXXA is not recommended
for the tr
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