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Savient Provides Update on Pegloticase BLA
Date:2/12/2009

ve in the relative benefit to risk profile of the safety and efficacy of this exciting product candidate when used in treating patients who suffer from treatment failure gout," said Paul Hamelin, President.

Key Amendments to the BLA

  • Clearer Data on Cardiovascular Profile. The results of the Company's independent post hoc both blinded and unblinded cardiovascular adjudication provided additional data, which clarified the previous understanding of the cardiovascular profiles of pegloticase. Further details of these findings are outlined below.

  • Updated Immunogenicity Guidance. With additional review and analyses, the Committee and its experts concluded that a clinically important immune response in pegloticase can be detected within the first 4 months through monitoring serum uric acid in normal medical practice patterns. A lack of uric acid response correlates with high levels of antibody production. The Company expects this to enable physicians to more quickly identify patients who should discontinue treatment.

  • Revised REMS Program. The Committee determined the Company's application would be strengthened by revising the Risk Evaluation and Mitigation Strategy (REMS) program. The revised REMS program proposed is based on an Elements To Assure Safe Use (ETASU) program. ETASU is a performance-linked access program for prescribers, infusion sites and patients that will have to enroll in this annual program and be certified in order to prescribe, administer or receive pegloticase. The Company also revised its previously proposed 1,000 patient observational study to be an expanded voluntary registry of up to 3,000 patients. The expanded registry will allow the Company to capture additional information about both the cardiovascular and immunogenicity profiles.

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SOURCE Savient Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

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