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

hase 3 trials, there was a 2:2:1 randomization used, meaning that 4 times as many patients were on drug than placebo. However, in the Open Label Extension study virtually all patients were on drug with only 2 going on observation. The panel determined the following:

  • Combined, and as previously reported in October 2008, there were 5 deaths in the pegloticase treatment arms of the Phase 3 trials and Open Label Extension study compared with 3 deaths in the placebo comparator arm of the Phase 3 trials.

  • As of February 6, 2009, there has been only one additional death in the Open Label Extension study and this was of infectious origin.

Next Steps with the FDA

Upon review of these amendments, the FDA determined that the additional information contained in these submissions constituted a major amendment to the pegloticase BLA, which allowed the FDA under the Prescription Drug User Fee Act (PDUFA) regulations to extend the review period. In order to allow the agency time to consider these amendments, the FDA has notified the Company that the pegloticase BLA priority review PDUFA action date has been extended by three months to July 30, 2009. Given the extended action date, the FDA has also notified the Company that the Advisory Committee meeting previously scheduled for March 5, 2009 will be rescheduled. Savient will provide additional details regarding the rescheduling of the Advisory Committee meeting when a specific date and time have been determined.

Commercialization Update

"While we are eager to move the process forward as quickly as possible, the change in schedule does not impact our planning related to commercialization. The Company has always had a commercialization launch plan that parallels the FDA review process and that will be adjusted to meet the new PDUFA d
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SOURCE Savient Pharmaceuticals, Inc.
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