Takeda Pharmaceutical Company Limited (NYSE:TAK) announced on Friday that the Japanese Ministry of Health, Labour and Welfare has approved HYQVIA (Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase) for the treatment of patients with agammaglobulinemia or hypogammaglobulinemia.
These conditions, characterized by low or absent antibody levels, result in an increased risk of serious infections. This approval introduces the first and only facilitated subcutaneous immunoglobulin (fSCIG) therapy in Japan, offering patients a new treatment option.
HYQVIA combines subcutaneous immunoglobulin (10%) with recombinant human hyaluronidase (rHuPH20), which facilitates larger volume infusions by increasing the dispersion and absorption of immunoglobulin in subcutaneous tissue.
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This allows for less frequent dosing, with treatments every 3 to 4 weeks, compared to weekly or bi-weekly infusions with other subcutaneous immunoglobulin treatments.
This flexibility eliminates the need for venous access, offering patients greater convenience.
The approval was based on data from two Phase 3 clinical trials conducted in Japan and North America.
These studies showed that HYQVIA maintained stable IgG levels comparable to intravenous or other subcutaneous immunoglobulin treatments, with manageable side effects such as mild fever and injection site reactions.
Takeda's commitment to offering differentiated immunoglobulin therapies is further demonstrated by this approval, which expands its portfolio in Japan.
The company also continues to invest in local manufacturing to meet the growing demand for plasma-derived therapies as education and diagnosis of immunodeficiencies improve.
Price Action: TAK shares are trading higher by 1.07% to $13.28 premarket at last check Friday.
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