HIZENTRA (immune globulin [human]) 20% liquid by CSL Behring
The FDA has approved CSL Behring's Hizentra (immune globulin [human] 20% liquid for subcutaneous injection) for the once weekly treatment of primary immunodeficiency. This approval was based on data from a prospective, open-label, multicenter, single-arm, clinical study evaluating Hizentra in adult and pediatric patients. In the study, patients previously receiving IVIg treatments every three or four weeks were switched to weekly subcutaneous administration of Hizentra for 15 months (a three-month wash-in/wash-out period followed by a 12-month efficacy period). The efficacy of Hizentra was analyzed in 38 subjects who received at least one infusion after the wash-in/wash-out period.