CSL Behring Gains Japan Approval

Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved CSL Behring‘s Hizentra for the treatment of primary immunodeficiency (PID) and for the treatment of secondary immunodeficiency (SID).

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 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.