TAKEDA PHARMACEUTICAL COMPANY LIMITED HyQvia®, which may be administered at home, will provide children and adolescents living with immunodeficiencies with a new treatment option
"This approval is significant as it gives children and adolescents living with immunodeficiencies another treatment option," said
There are more than 300 genetic defects and disorders of the immune system that are recognized as PI. These forms range widely in severity and symptoms. On average, 1 in every 1,200 individuals are affected by this disease and early diagnosis and treatment are vital in saving lives. Approximately 29,000 Canadians suffer from PI and over 70% are undiagnosed.2
"The pediatric indication for HyQvia provides another treatment option for patients impacted by immunodeficiency disorders," said Jefferson Tea, Vice President, Medical & Scientific Affairs, Takeda. "We are committed to creating innovative solutions for Canadians living with immunodeficiency and are excited that parents and caregivers will have the option to support administration of this treatment to their children in their own home."
Authorization for the treatment of pediatric patients was based on two pivotal studies in 66 patients ranging in age from 2 to 16 years. HyQvia was shown to be efficacious and no new safety signals were detected when compared to the adult population. Based on evidence from the pivotal, prospective, open-label, non-controlled Phase 3 clinical study in 44 pediatric patients with PI, there were no clinically meaningful differences in trough IgG levels across age groups. During the 12-month trial period, it was shown to be efficacious with respect to the occurrence of acute serious bacterial infections (ASBIs), a primary endpoint.1
The mean rate of ASBIs per subject-year was 0.04 and was statistically significantly lower (p<0.001) than the threshold rate of 1.0 ASBI per subject-year favoring efficacy of this treatment in pediatric subjects with PI. The efficacy of the treatment in this study was further demonstrated by the overall rate of infections per subject, which is consistent with results obtained in the pivotal clinical study. The mean rate of all infections per subject-year was 3.20, with an upper limit of the 95% CI of 4.05. The results of Study 161503 indicated similar safety profiles to adults.1
About HyQvia®
HyQvia is indicated as replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in adult and pediatric patients 2 years of age and older.1 This therapy is used in patients who do not have enough antibodies in their blood or have a weakened immune system and get frequent infections.1
Consult the product monograph for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The product monograph is also available through our medical information department.
About Immunodeficiency
Primary immunodeficiency disorder (PID) refers to a large heterogeneous group of disorders that result from defects in immune system development and/or function. PIDs are broadly classified as disorders of adaptive immunity (i.e., T cell, B-cell or combined immunodeficiencies) or of innate immunity (e.g., phagocyte and complement disorders). Although the clinical manifestations of PIDs are highly variable, many disorders involve an increased susceptibility to infection.2
Secondary immune deficiencies or acquired deficiencies, more frequent than primary immune deficiencies, are problems of the immune system that are not genetic and which are caused by external factors including viruses (such as HIV), severe malnutrition, certain chronic diseases such as diabetes, immunosuppressive medication or chemotherapy, certain cancers such as leukemia, and the absence of the spleen.3
About Takeda Canada Inc.
References
1- | HyQvia® Product Monograph. June, 2024 |
2- | Springer.com Accessed June, 2024. Primary immunodeficiency | Allergy, Asthma & Clinical Immunology (springer.com) |
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SOURCE
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