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Canadian Blood Services Includes HyQvia® on its Formulary

November 6, 2023

HyQvia® availability further supports the delivery of innovative therapies for Canadians living with immunodeficiencies

TORONTO, ON – November 6, 2023 –Takeda Canada Inc. (“Takeda”) is pleased to announce that Canadian Blood Services (CBS) has included 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 patients on its formulary.

“Living with an immunodeficiency can bring significant challenges and it’s important to me that my patients continue to have access to innovative treatments that support them in their journey,” says Dr. Stephen D. Betschel, Departmental Division Director of Clinical Immunology, Department of Medicine, University of Toronto. “This contract is welcome news and will have a positive impact for many immunodeficiency patients across Canada.”

“At Immunity Canada, we appreciate the significance additional treatment options provide patients,” says Whitney Goulstone, Executive Director, Immunity Canada. “As a community, we applaud Canadian Blood Services and Takeda’s efforts in this important step forward for Canadians with immunodeficiencies.”

While all subcutaneous immunoglobulin treatments can be self-administered, only HyQvia® offers patients the option of subcutaneous once-monthly (every three or four weeks) dosing. HyQvia® received marketing authorization by Health Canada in January 2022.

“We are pleased to share this positive development to support the thousands of Canadians living with immunodeficiency disorders,” says Rute Fernandes, President & General Manager, Takeda in Canada. “The availability of HyQvia® further demonstrates the ongoing commitment of governments, Canadian Blood Services and Takeda to meet the needs of immunodeficiency patients across the country. We look forward to the positive impact that HyQvia® will bring for Canadians.”

About HyQvia®1

HyQvia® is indicated as replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in adult patients. HyQvia® is used in patients who do not have enough antibodies in their blood or have a weakened immune system and get frequent infections.

The marketing authorization of HyQvia® by Health Canada 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.

For more information visit the HyQvia® product monograph here.

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: takeda.com/en-ca

Media Contacts:

Amanda Jacobs

[email protected]

+1 647-798-2231

1 HyQvia. Product Monograph. December 9, 2022.