A new study conducted in Japan supports the previously demonstrated safety and efficacy of Hizentra (Immune Globulin Subcutaneous [Human]), from CSL Behring, for the treatment of primary Immunodeficiency (PID). The Phase III study, conducted in patients who converted from intravenous immunoglobulin (IVIG) treatment, found that a dose-equivalent switch to Hizentra therapy maintained serum IgG (immunoglobulin) at a similar level of trough concentration than previous IVIG therapy.
Results showed that Hizentra provided effective passive immunity in adults and children to control most recurrent infections and improved patients' overall quality of life. Findings demonstrated that Hizentra produced serum IgG trough concentrations higher than those seen during previous IVIG therapy. Mean serum IgG levels increased from 6.51 (1.32) g/L in the IVIG period to 7.28 (1.47) g/L in the SCIg efficacy period. During the efficacy period, no serious bacterial infections were reported; 11 patients experienced a non-serious infection. Ninety-six percent of the patients enrolled experience at least one AE; most common AEs were local reactions of mild intensity. No related serious AEs were reported. The data were presented at the 15th Biennial Meeting of the European Society for Immunodeficiencies. Based on these results, CSL Behring submitted the new drug application (NDA) for Hizentra to the Pharmaceutical and Medicines Devices Agency (PMDA) in Japan on 28 September, 2012.