Takeda Announces Approval of HYQVIA® 10% S.C. (Subcutaneous) Injection Set in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia
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HYQVIA [Immune Globulin Infusion
10% (Human) with Recombinant Human Hyaluronidase] is the First and Only Facilitated Subcutaneous Immunoglobulin (fSCIG) Approved inJapan for Agammaglobulinemia and Hypogammaglobulinemia - Administration of Recombinant Human Hyaluronidase Prior to Immunoglobulin Facilitates Subcutaneous Infusion of Larger Volumes, Potentially Reducing Frequency and Giving Patients More Flexibility
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Approval Expands Takeda’s Portfolio of Differentiated Immunoglobulin Therapies and Reflects the Company’s Commitment to Bring High-Quality Plasma-Derived Therapies to Patients in
Japan
HYQVIA is the first plasma-derived therapy for subcutaneous injection in
The approval is based on data from two pivotal Phase 3, open-label, non-controlled studies evaluating the efficacy, safety, tolerability and pharmacokinetics in Japanese subjects with PID (NCT05150340, NCT05513586). In these studies, the efficacy and safety profile of HYQVIA in 16 patients aged 2 years or older in
“We are delighted that HYQVIA, approved in more than 40 countries worldwide, has now been approved in Japan,” said Naoyoshi Hirota, Regional Head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit in
“There is a high unmet need for plasma-derived therapies (PDTs) in patients in
With this approval, Takeda is now able to offer a range of SCIG therapies to patients based on their individual administrative needs, reflecting the company’s commitment to offer patients in
About Agammaglobulinemia or Hypogammaglobulinemia
Agammaglobulinemia is an inherited disorder caused by a gene defect that blocks the growth of normal, mature immune cells called B lymphocytes3. Hypogammaglobulinemia is a condition in which patients have low levels of antibodies due either to inherited genetic conditions (PID) or secondary effects (SID) – like chemotherapy, certain comorbid disorders, or immunosuppressants2. Individuals with any form of antibody deficiency frequently experience recurring and/or severe infections, and immunoglobulin replacement therapy can increase the level of antibodies in the body.
About Primary Immunodeficiency and Secondary Immunodeficiency
Primary immunodeficiency describes a heterogeneous group of more than 480 rare genetic diseases wherein part of the immune system is missing or not functioning properly4. Secondary immunodeficiency is defined as an acquired impairment of the immune response resulting from an underlying condition or factors extrinsic to the immune system. SID may occur as a consequence of malnutrition, metabolic disorders, use of immunosuppressive medications, chronic infections, malignancies, or severe trauma5. Due to their impaired immune system, patients with PID and SID may be more susceptible to infection, and it may take longer to recover from it. In patients with antibody deficiency and increased susceptibility and/or persistent infections, substitution with functional antibodies (immunoglobulin replacement therapy) is the standard of care to support the immune system's functioning5.
About HYQVIA®
HYQVIA is the combination product for subcutaneous injection containing one each vial of Subcutaneous Immunoglobulin
HYQVIA Product Overview in
Brand Name |
HYQVIA |
Generic Name |
pH4 Treated Acid Human Globulin (Subcutaneous Injection) Vorhyaluronidase Alfa (Genetical Recombination) |
Indications |
Agammaglobulinemia or Hypogammaglobulinemia |
Dosage and Administration
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Human immunoglobulin G is administered subcutaneously at the same site within approximately 10 minutes after the subcutaneous injection of vorhyaluronidase alfa (genetical recombination). Initiate the treatment with human immunoglobulin G and vorhyaluronidase alfa (genetical recombination) at 1/3 or 1/4 of the doses described below, and then the doses are titrated up. Note that the dosing interval should be extended depending on the doses. •Usually, 150 – 600 mg (1.5 – 6 mL)/kg of body weight of human immunoglobulin G is administered once every 3 weeks or 200 – 800 mg (2 – 8 mL)/kg of body weight of human immunoglobulin G is administered once every 4 weeks. •Vorhyaluronidase alfa (genetical recombination) is administered at the dose of 80 units (0.5 mL) per 1 g of human immunoglobulin G. The dose and the number of doses per 3 or 4 weeks may be adjusted according to the patient’s condition. |
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in
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REFERENCES
1 HYQVIA
2 Pimenta et al. Hypogammaglobulinemia: a diagnosis that must not be overlooked. BJMBR. 2019;52(10): e8926.
3 National Organization for Rare Disorders https://rarediseases.org/rare-diseases/agammaglobulinemia/
4 Tangye et al. Human Inborn Errors of Immunity: 2022 Update on the Classification from the International Union of Immunological Societies Expert Committee. J Clin Immunol. 2022;42(7):1473-1507.
5 Tuano KS, Seth N, Chinen J. Secondary immunodeficiencies: An overview. Ann Allergy Asthma Immunol. 2021;127(6):617-626.
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Kristine Kelly
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Shigeyuki Matsui
Shigeyuki.Matsui@takeda.com
+81 (80) 3594-2460
Source: Takeda Pharmaceutical Company Limited