TOKYO (dpa-AFX) - Takeda Canada Inc., the Canadian organization of Takeda Pharmaceutical Company Limited (TAK), Thursday has announced that Health Canada has extended the marketing authorization for HyQvia 'normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution' to include chronic inflammatory demyelinating polyneuropathy - CIDP as a maintenance therapy.
This approval allows HyQvia to be used after stabilization with intravenous immunoglobulin - IVIG to prevent relapse of neuromuscular disability and impairment in adults.
HyQvia is the only subcutaneous immunoglobulin infusion in Canada that can be administered as infrequently as once every two, three, or four weeks. Patients have the option to receive the infusion from a healthcare professional or self-administer it at home after proper training, reducing the need for hospital visits.
CIDP is an inflammatory disorder affecting the peripheral nerves, leading to progressive weakness, numbness, and tingling in the limbs. If untreated, symptoms persist and worsen over time. The condition results from damage to the myelin sheath, which insulates the nerves. Early and aggressive treatment can help limit nerve damage and improve the quality of life for those affected. CIDP can occur at any age and affects both men and women.
The expanded approval is supported by findings from the Phase 3 ADVANCE-1 trial, a multicenter, placebo-controlled study that assessed HyQvia's efficacy and safety in preventing CIDP relapse. Results demonstrated a significant reduction in relapse rates compared to placebo-15.5% versus 31.7%-with a treatment difference of -16.2%.
Common side effects reported in at least five percent of cases include localized infusion site reactions, headache, fatigue, nausea, fever, increased blood pressure, elevated pancreatic enzymes, abdominal pain, back pain, and limb pain.
TAK is currently trading at $15.07 or 0.33% higher on the NYSE.
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