CSL Behring’s Hizentra approved in Japan for PID and SID

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Hizentra (immune globulin subcutaneous [human]) for the treatment of primary immunodeficiency (PID) and for the treatment of secondary immunodeficiency (SID), from CSL Behring, a unit of Australia’s CSL Ltd (CSL: AX).

Hizentra is now the first and only 20% subcutaneous immunoglobulin (SCIg) therapy in the world for the treatment of these conditions, both of which belong to group of rare and serious diseases of the immune system. The Japanese MHLW approval marks the first time any SCIg therapy has been approved for use in Japan, the company noted.

The approval was based on a Phase III study of 25 Japanese patients that found when patients converted from intravenous immunoglobulin (IVIg) treatment to dose-equivalent Hizentra therapy, serum IgG (immunoglobulin), trough concentrations increased to levels higher than those seen with their previous IVIG therapy. Results showed that Hizentra provided effective passive immunity in adults and children, which controlled most recurrent infections and improved patients' overall quality of life.