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Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)
Date:8/2/2009

XA manufactured using the proposed commercial manufacturing process. The Company currently expects that it will seek to address this issue by reverting to and revalidating the manufacturing process used to produce KRYSTEXXA for the Phase 3 clinical trials.

The complete response letter also stated that the FDA has determined that a REMS is necessary for KRYSTEXXA consisting of:

  • A Medication Guide to ensure the safe and effective use of KRYSTEXXA by patients,
  • A Communication Plan directed to healthcare providers likely to prescribe KRYSTEXXA to support the dissemination of information about the risks of severe infusion reactions and possible anaphylaxis, the risk of severe adverse reactions in administering KRYSTEXXA to patients with glucose-6-phopshate dehydrogenase (G6PD) deficiency and major cardiovascular events, and
  • An Assessment Plan to monitor and assess the effectiveness of the Medication Guide and Communication Plan in communicating to patients and physicians an understanding of the risks of KRYSTEXXA treatment.

The complete response letter included additional CMC comments focused on tightening manufacturing parameters and narrowing analytical specifications associated with commercial production. The Company was also informed that its resubmission to the FDA in response to the complete response letter must include an update of safety data from all on-going studies. Additionally, the Company's drug substance manufacturer BTG-Israel has already provided a work plan to remediate observations arising from the FDA pre-approval inspection of BTG-Israel's manufacturing facility and a satisfactory inspection report is required prior to the approval of KRYSTEXXA.

"While our timeline for resubmission to the FDA is subject to a number of uncertainties, we currently believe that we can target completion of our resubmission for early 201
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SOURCE Savient Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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