Takeda Says Japan Approves CUVITRU Subcutaneous Immunoglobulin For Patients With Agammaglobulinemia

(RTTNews) - Takeda Pharmaceutical Co. Ltd. (TAK) 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 agammaglobulinemia or hypogammaglobulinemia disorders.

This is 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 approval marks Takeda's first subcutaneous immunoglobulin (SCIG) therapy for patients in Japan.

The approval is based on results from a Phase 3 clinical trial that evaluated the efficacy, safety, tolerability and pharmacokinetics of CUVITRU in Japanese patients with PID, as well as two Phase 2/3 clinical trials conducted in patients with PID in North America and Europe.

Results from the clinical trial in 17 patients in Japan confirmed its efficacy and safety profile and CUVITRU was well-tolerated. Previously reported clinical trial results also confirmed the efficacy and safety of CUVITRU.