TORONTO, ON – July 6, 2022 – Takeda Canada Inc. is pleased to announce that Health Canada has issued the marketing authorization (Notice of Compliance) for HyQvia® (Normal Immunoglobulin (Human)10% & Recombinant Human Hyaluronidase solution for subcutaneous infusion) as replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in adult patients2.
On April 29 the Institut national d’excellence en santé et en services sociaux (INESSS) issued a positive recommendation for HyQvia® for reimbursement in Quebec. This was followed by a positive recommendation from the Canadian Agency for Drugs and Technologies in Health (CADTH) for HyQvia® on July 4, 2022.
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, which is significantly less than current subcutaneous treatment options1.
“The approval by Health Canada of HyQvia® will hopefully add an additional and important option for patients who require immunoglobulin replacement therapy. Its availability would address unmet patient needs by providing a subcutaneous immunoglobulin administered therapy with a dosing regimen that is less frequent than currently available subcutaneous therapeutic options,” said Dr. Stephen D Betschel, Departmental Division Director of Clinical Immunology, Department of Medicine, University of Toronto. “Administering a treatment less frequently will likely give patients more flexibility and decrease the burden of treatment. As a treater of patients with immunodeficiencies, anything that can give patients more choice while providing a safe efficacious treatment is welcome news.”
The approval of HyQvia® 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®3. 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 year3. The most frequently reported adverse reactions in the clinical studies were injection site reactions4.
The approval of HyQvia® provides immunodeficiency patients with another treatment option, the first in many years, that can be administered at home and provides greater dosing flexibility.
“Over the past two years, the pandemic has put a spotlight on the importance of treatments for patients that are immunocompromised,” said Rute Fernandes, General Manager, Takeda Canada. “Takeda is dedicated to bringing innovative treatments, such as HyQvia®, to Canadian patients. We will continue to work with all stakeholders to ensure timely access for patients.”
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: takeda.com/en-ca.
1 HyQvia Product Monograph: page 5
2 HyQvia Product Monograph: page 4
3 HyQvia Product Monograph: page 24
4 HyQvia Product Monograph: page 12