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Takeda (TAK) Canada announced that Health Canada has expanded the marketing authorization for HyQvia for chronic inflammatory demyelinating polyneuropathy as maintenance therapy after stabilization with intravenous immunoglobulin to prevent relapse of neuromuscular disability and impairment in adults. HyQvia is the only up to once monthly 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. 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. The results showed a clinically meaningful reduction of CIDP relapse rate with HyQvia versus placebo, 15.5% vs 31.7% in the placebo groups. The estimated treatment difference in the proportion of subjects who experienced a relapse was -16.2.
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