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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.
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| 1 HyQvia®(normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion), Product Monograph, Takeda Canada Inc. (March 13, 2025). Available at: https://takeda.info/en-ca-hyqviapm. |
| 2 GBS/CIDP Foundation of Canada. CIDP – Chronic Inflammatory Demyelinating Polyneuropathy. 2025. Available at: https://www.gbscidp.ca/cidp/ |
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"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."