Takeda gains approval for Cuvitru in Japan

25 September 2023

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the use of Cuvitru (immune globulin subcutaneous [human], 20% solution).

The approval is for the treatment of in patients aged two years and older with agammaglobulinemia or hypogammaglobulinemia disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID).

The drug came to Japanese pharma giant Takeda (TYO: 4502) along with its $62 billion acquisition in 2019 of Ireland-based Shire, which first gained approval of Cuvitru in the USA in 2016.

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