Héma-Québec to Reimburse HyQvia® for the Treatment of Immunodeficiencies in Adult and Pediatric Patients Over 2 Years of Age

TORONTO, Jan. 29, 2025 /CNW/ - Takeda Canada Inc. (Takeda) is pleased to announce that Héma-Québec has added HyQvia^®– (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) as a replacement therapy for primary humoral immunodeficiency (PI) or secondary humoral immunodeficiency (SI) – to its list of plasma products distributed in Quebec.¹ The treatment will now be reimbursed for adult and pediatric patients two years of age and older starting January 30, 2025,

HyQvia received Health Canada market authorization for the adult indication in January 2022 and the pediatric indication (2 years of age and older) in June 2024. HyQvia is the only subcutaneous immune globulin (SCIG) infusion that can be administered once monthly (every three or four weeks).¹ It is used in patients that do not have enough antibodies in their blood or have a weakened immune system and get frequent infections.²

PI is an umbrella term for over 450 genetic defects and disorders of the immune system.³ These forms range widely in severity and symptoms. On average, one in 1,200 individuals are affected by this disease⁴ and early diagnosis and treatment are vital in saving lives. Approximately 29,000 Canadians suffer from PI and over 70 per cent are undiagnosed.⁵ SI, or acquired immunodeficiencies, are problems of the immune system that are not genetic.⁶ They 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.⁷

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"Inborn errors of immunity are rare. Patients commonly experience long delays from the onset of symptoms to diagnosis and appropriate treatment for their condition," said Hugo Chapdelaine, MD Director, Adult Clinical Immunology Clinic, Montreal Clinical research Institute. "The reimbursement of HyQvia is welcome news as it is important that patients in Quebec continue to have access to innovative treatments."

"Reimbursement for HyQvia is a major development for Quebecers living with PI and SI giving them a new treatment option to manage these often-debilitating conditions," said Jacques Dagnault, Past President, member of the Executive Council of the Association des Patients Immunodéficiences du Québec (APIQ)]. "It's important that our government continues to increase access to safe and effective treatments for those living with immunodeficiency and other rare diseases."

"We are pleased with this reimbursement that will see people in Quebec with PI and SI have improved access to HyQvia," said Vatroslav Mateljic, General Manager, Takeda Canada. "Takeda has an ongoing commitment to developing innovative treatments for Canada's rare disease community and we continue to work collaboratively with key stakeholders like Héma-Québec to get these treatments to those who need them most."

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. HyQvia is used in patients who do not have enough antibodies in their blood or have a weakened immune system and get frequent infections. HyQvia also provides flexibility for patients as it may be infused monthly. The authorization for the treatment of adult patients is based on four clinical trials in patients with primary immunodeficiency, including a pivotal efficacy trial in which eighty-three patients received a total of 1359 infusions of HyQvia. The annualized rate of acute serious bacterial infections (ASBI) while treated with HyQvia in the study was 0.025 (upper 99% confidence limit of 0.046), which is significantly less than the rate of one infection per year. The most frequently reported adverse reactions in the clinical studies were injection site reactions. ¹

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

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¹ HyQvia^® Product Mongraph. January 2024. https://pdf.hres.ca/dpd_pm/00064356.PDF

² Ibid.

³ Immune Deficiency Foundation. Genetics and the immune system. 2021. Available at: https://primaryimmune.org/resources/news-articles/genetics-and-immune-system Accessed January 2025.

⁴ McCusker, C., Upton, J. & Warrington, R. Primary immunodeficiency. Allergy Asthma Clin Immunol 14 (Suppl 2), 61 (2018). https://doi.org/10.1186/s13223-018-0290-5 Accessed January 2025.

⁵ Ibid.

⁶ The Association of Allergists and Immunologists of Québec. Secondary immunodeficiency Available at: https://allerg.qc.ca/Information_allergique/6_2_secondaire_en.html Accessed December 2024. Accessed January 2025.

⁷ Ibid.

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/ .

SOURCE Takeda Canada Inc.

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