HyQvia®, which may be administered at home,
will provide children and adolescents living with
immunodeficiencies with a new treatment option
TORONTO, June 21,
2024 /CNW/ - Takeda Canada Inc. ("Takeda") is
pleased to announce that Health Canada has expanded the marketing
authorization (NOC) for HyQvia® (normal immunoglobulin
[human] 10% and recombinant human hyaluronidase solution for
subcutaneous infusion) as a replacement therapy for primary humoral
immunodeficiency (PI) and secondary humoral immunodeficiency (SI)
in pediatric patients 2 years of age and older. HyQvia is the only
subcutaneous immune globulin (SCIG) infusion that can be
administered every three or four weeks.1
![Takeda Logo (CNW Group/Takeda Canada Inc.) Takeda Logo (CNW Group/Takeda Canada Inc.)](https://mma.prnewswire.com/media/2444162/Takeda_Canada_Inc__Takeda_s_HyQvia_%C2%A0Approved_as_Replacement_Ther.jpg)
"This approval is significant as it gives children and
adolescents living with immunodeficiencies another treatment
option," said Whitney Ayoub
Goulstone, Executive Director, ImmUnity Canada. "Children
living with immunodeficiencies can be severely impacted as it
affects them physically, emotionally and socially. Our organization
welcomes treatment options for patients in Canada as this is to the benefit of better
health outcomes and patient preference."
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.
Takeda Canada Inc. is the Canadian organization of Takeda
Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a
global, values-based, R&D-driven biopharmaceutical leader
headquartered in Japan, committed
to discovering and delivering life-transforming treatments, guided
by our commitment to patients, our people and the planet. Takeda
focuses its R&D efforts on four therapeutic areas: Oncology,
Rare Genetics and Hematology, Neuroscience, and Gastroenterology
(GI). We also make targeted R&D investments in Plasma-Derived
Therapies and Vaccines. We are focusing on developing highly
innovative medicines that contribute to making a difference in
people's lives by advancing the frontier of new treatment options
and leveraging our enhanced collaborative R&D engine and
capabilities to create a robust, modality-diverse pipeline. Our
employees are committed to improving quality of life for patients
and to working with our partners in health care in approximately 80
countries and regions. For more information,
visit: https://www.takeda.com/en-ca/
References
1-
|
HyQvia® Product
Monograph. June, 2024
|
2-
|
Springer.com Accessed
June, 2024. Primary immunodeficiency | Allergy, Asthma &
Clinical Immunology (springer.com)
|
3-
|
The Association of
Allergists and Immunologists of Québec. Secondary immunodeficiency.
Accessed June , 2024.
https://allerg.qc.ca/Information_allergique/6_2_secondaire_en.html
|
SOURCE Takeda Canada Inc.