Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare for HYQVIA, a facilitated subcutaneous immunoglobulin (fSCIG) therapy, for patients with agammaglobulinemia or hypogammaglobulinemia. These conditions, characterized by low antibody levels, increase the risk of serious recurring infections stemming from primary or secondary immunodeficiencies. This approval marks the first fSCIG treatment option available in Japan.
This approval is particularly impactful for Japanese patients who previously relied on intravenous or conventional subcutaneous immunoglobulin treatments, often requiring weekly or bi-weekly infusions. HYQVIA’s less frequent dosing schedule (every 3 or 4 weeks) offers a significant improvement in quality of life by reducing the burden of frequent infusions and eliminating the need for venous access. This can lead to greater patient autonomy and potentially improved adherence to therapy. The availability of HYQVIA also addresses the growing unmet need for plasma-derived therapies in Japan, where increasing awareness and improved diagnostic rates are expected to drive further demand.
HYQVIA combines immunoglobulin 10% with recombinant human hyaluronidase PH20 (rHuPH20). The rHuPH20 facilitates the dispersion and absorption of immunoglobulin, allowing larger volumes to be administered subcutaneously. The approval is supported by data from two pivotal Phase 3 studies conducted in Japan, demonstrating comparable efficacy to existing treatments while exhibiting a manageable safety profile. The most common adverse reactions were pyrexia and localized skin reactions at the injection site.
This approval signifies a step forward in the treatment landscape for immunodeficiency disorders in Japan. It offers patients a more convenient and potentially less disruptive treatment option, potentially leading to improved disease management and quality of life. It also reinforces Takeda’s commitment to expanding therapeutic options for patients in Japan, particularly in the realm of plasma-derived therapies. The increased availability of diverse treatment options, including HYQVIA, positions healthcare providers to tailor treatment strategies to individual patient needs and preferences.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
