IgG Next Generation is a newly developed polyvalent immunoglobulin preparation for intravenous administration from human plasma for the treatment of immunodeficiencies and autoimmune diseases.
IgG Next Generation will be submitted for approval in several European countries and USA. Clinical development is about to be completed in two pivotal trials: phase III Study No. 991 for the treatment of patients with primary immunodeficiencies (PID) and Phase III Study No. 992 for the treatment of patients with immune thrombocytopenia (ITP). Study No. 991 has completed enrollment; the one-year treatment phase will continue until the end of Q1 2020. Study No. 992 has already been completed and evaluated. The results confirm the expectations regarding efficacy and safety of the drug.