Savient updates on Puricase Ph III trial
New Jersey, USA-based Savient Pharmaceuticals has announced further information related to infusion reactions and deaths for its Phase III clinical trials for Puricase (pegloticase), which is being developed for treatment-failure gout patients.
The firm said its preliminary analysis indicated that 19 patients or 11% of pegloticase treated subjects experienced an infusion reaction termed either "serious" or "severe." Based on further information that has become available, it has determined that the number of patients who experienced a "severe" or "serious" infusion reaction is 18, a reduction of one due to a patient whose adverse event occurred after departing the clinical site post-infusion.
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