Takeda Pharmaceutical (TAK) said Friday that the Japanese Ministry of Health, Labor and Welfare has approved the use of Hyqvia in patients with agammaglobulinemia or hypogammaglobulinemia.
The two rare disorders are characterized by low levels or the absence of antibodies and an increased risk of serious infections caused by primary or secondary immunodeficiency, the company said.
Hyqvia is a plasma-derived therapy for subcutaneous injection that combines one vial of immunoglobulin 10% and one vial of recombinant human hyaluronidase, the company said.
The approval was based on results from two 16-patient phase 3 studies in Japan and two phase 3 clinical trials in North America.
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