Takeda's HyQvia® receives expanded market authorization as maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP)

HyQvia is the only up to once monthly (every 2, 3 or 4 weeks) immunoglobulin subcutaneous infusion to treat CIDP in Canada

TORONTO, March 27, 2025 /CNW/ - Takeda Canada Inc. (Takeda) is pleased to announce that Health Canada has expanded the marketing authorization for HyQvia® (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) for chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin (IVIG) to prevent relapse of neuromuscular disability and impairment in adults.¹

HyQvia is the only up to once monthly (every 2, 3 or 4 weeks) subcutaneous immunoglobulin infusion to treat CIDP in Canada and can be administered by a healthcare professional or self-administered with training, so patients do not need to go to a hospital or clinic for their infusion.¹

CIDP is an inflammatory disorder of the peripheral nerves. There is an increasing weakness as well as numbness and tingling of the legs and arms which can develop over a period of a few months and symptoms continue if untreated.² It is caused by damage to the covering of the nerves, called the myelin.² If treated early and aggressively, therapies can limit the damage to the nerves and contribute to a better quality of life.² CIDP can affect people at any age or gender.²

This approval is based on data from the pivotal Phase 3 ADVANCE-1 trial, which was a multicenter, placebo-controlled, double-blinded study that evaluated the efficacy and safety of HyQvia as a maintenance therapy to prevent relapse in patients with CIDP.¹ The results showed a clinically meaningful reduction of CIDP relapse rate with HyQvia versus placebo, 15.5% (95% CI: 8.36, 26.84) vs 31.7% (95% CI: 21.96, 43.39) in the placebo groups. The estimated treatment difference in the proportion of subjects who experienced a relapse was -16.2 (95% CI: -29.92, -1.27).¹

The most likely side effects that occurred at rates of five per cent or higher, are: local reactions at the infusion site, headache, fatigue, nausea, fever, increase blood pressure, increased levels of enzymes made by the pancreas, abdominal pain, back pain, and pain in arms or legs.

Quotes

"CIDP is a debilitating disorder which sees progressive weakness and sensory loss in the limbs caused by the body's immune system and unfortunately treatments to date have been limited," said Dr. Vera Bril, Professor of Medicine (Neurology) at the University of Toronto (UofT), Director of the Neuromuscular Section, Division of Neurology, UofT and University Health Network. "It's great to see a new treatment option for patients affected by this neuromuscular disorder to give them a chance at better managing their condition."

"We are pleased to see HyQvia receive another indication to help Canadians manage this challenging neuromuscular disorder," said Vatroslav Mateljic, General Manager, Takeda. "Takeda remains committed to helping the millions of Canadians living with rare diseases like CIDP through the development of innovative new treatments to improve their quality of life."

"Gaining a new treatment indication within Canada for CIDP is welcomed," said Donna Hartlen, Executive Director, GBS/CIDP Foundation of Canada. "This will give our CIDP patients and specialists more options for individualized healthcare." 

About HyQvia^®

HyQvia (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) is a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin (IVIG) to prevent relapse of neuromuscular disability and impairment in adults. HyQvia is also 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 infused under the skin into the fatty subcutaneous tissue. This product contains IG collected from human plasma. IG are antibodies that maintain the body's immune system. The hyaluronidase part of HyQvia facilitates the dispersion and absorption of IG in the subcutaneous space between the skin and the muscle. This new treatment is infused up to once a month (every two, three or four weeks for CIDP; every three or four weeks for PI).

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 Takeda Canada Inc.

Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited ((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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