Development pipeline

IgG Next Generation

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 has been successfully completed in two pivotal trials: phase III Study No. 991 for the treatment of patients with primary (congenital) immunodeficiencies (PID) and phase III Study No. 992 for the treatment of patients with immune thrombocytopenia (ITP). Final results of both studies confirm the expectations regarding efficacy and safety of the drug.

Press releases

Biotest Achieves Important Clinical Milestone for IgG N...

05.09.2019,

Biotest Achieves Important Clinical Milestone for IgG Next Generation- Phase III study in Primary Immune Thrombocytopenia (ITP) completed, data evaluation in progress, promising results - The study is ... [More]

Clinical trials

Title

Indication

Status

 
IgG Next Generation (Study 991) Primary Immune Deficiency (PID) Study completed

An open label, prospective, multicenter phase III study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT595 as replacement therapy in patients with primary immunodeficiency disease (PID)

Link clinicaltrialsregister.eu
 
IgG Next Generation (Study 992) Idiopathic Thrombocytopenic Purpura (ITP) Study completed

An open label, prospective, randomized, multicenter phase III study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP)

Link clinicaltrialsregister.eu