Takeda previously announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on
As the first and only facilitated subcutaneous immunoglobulin (fSCIG) for CIDP, HYQVIA offers the potential for patients to infuse up to once monthly (every two, three or four weeks), as the hyaluronidase component facilitates the dispersion and absorption of large immunoglobulin (IG) volumes in the subcutaneous space between the skin and the muscle. HYQVIA can be administered by a healthcare professional or self-administered in the comfort of a patient's own home after appropriate training.3
'Following the FDA approval of the HYQVIA CIDP indication in
CIDP is an acquired, immune-mediated condition affecting the peripheral nervous system that is characterized by progressive, symmetric weakness in distal and proximal limbs and impaired sensory function in the extremities.4 The role of IG therapy for this rare, debilitating and slowly progressing or relapsing disease has been well-established5 and is considered a standard of care for this complex and heterogeneous condition in guidelines from the
This approval is based on data from the pivotal Phase 3 ADVANCE-CIDP 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 global study included 132 adults with a confirmed diagnosis of CIDP who had remained on a stable dosing regimen of IVIG therapy for at least three months prior to screening. Results showed a clinically significant reduction in CIDP relapse rate with HYQVIA versus placebo 15.5% (95% CI: 8.36, 26.84) in the HYQVIA and 31.7% (95% CI: 21.96, 43.39) in the placebo groups. The treatment difference was -16.2 (95% CI: -29.92, -1.27), favoring HYQVIA over placebo.3
While adverse events (AEs) were more frequent with HYQVIA (79.0% of patients) than placebo (57.1%), severe (1.6% vs 8.6%) and serious AEs (3.2% vs 7.1%) were less common. The majority of AEs were mild or moderate, local, did not require suspension of infusions, and resolved without sequelae. The most common (reported in >5% of patients) causally related AEs included headache and nausea, as well as local AEs including infusion site pain, erythema, pruritis, and edema. 7 Overall, the safety profile observed in the ADVANCE-CIDP 1 trial was generally consistent with the existing EU Summary of Product Characteristics (SmPC).3
The centralized marketing authorization for HYQVIA in CIDP is valid in all EU member states as well as in
About HYQVIA
HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (IG) and is approved by the
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