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www.fdanews.com/articles/85041-vivaglobin-study-results-reported

VIVAGLOBIN STUDY RESULTS REPORTED

March 6, 2006

Data from a Phase III clinical study has demonstrated the safety and efficacy of Vivaglobin (Immune Globulin Subcutaneous [Human]), an immunoglobulin replacement therapy for treating patients with primary immunodeficiency (PI). Vivaglobin recently became the first and only FDA-approved subcutaneous Immunoglobulin treatment and can be safely self-administered by PI patients under a physician's care in the U.S.

In the study, 65 patients self-administered Vivaglobin at home every week for 12 months, for a total of 3,655 infusions. The annual rate of serious bacterial infections was 0.04 per patient per year, and the annual rate of any infection was 4.4 episodes per patient per year. No related serious adverse events were reported.