CSL Behring announced today that the Japanese Ministry of Health, Labour 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). Hizentra is now the first and only 20 percent 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. Results showed that Hizentra provided effective passive immunity in adults and children, which controlled most recurrent infections and improved patients' overall quality of life.
"We are extremely pleased to have secured this important regulatory approval for Hizentra in Japan," said Christopher Church, Vice President and General Manager, CSL Behring Asia Pacific Ltd. "For some years, Hizentra has been available in several areas of the world, making a positive difference for patients and healthcare professionals who seek innovative options for treating PID and SID. Today, it is gratifying to bring such an option to Japan, where Hizentra can address a clear, unmet medical need."
Stapokibart shows promise in reducing nasal congestion in seasonal allergy patients, study finds