25 September 2023 - Approval is based on clinical studies conducted in Japan, Europe and North America confirming the ffficacy and safety of Cuvitru [immune globulin subcutaneous (human), 20% solution].
Takeda today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of Cuvitru [immune globulin subcutaneous (human), 20% solution] in patients aged 2 years and older with agammaglobulinaemia or hypogammaglobulinaemia, disorders characterised by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency or secondary immunodeficiency.