Savient Pharmaceuticals, Inc. Marketing Authorization Application for KRYSTEXXA(R) Accepted for Review by European Medicines Evaluation Agency
Published: May 26, 2011
EAST BRUNSWICK, N.J., May 26, 2011 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (Nasdaq:SVNT - News) 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.