The US Food and Drug Administration (FDA) has approved Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HyQvia, Takeda) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
HyQvia, which combines immunoglobulin (Ig) with hyaluronidase, is administered subcutaneously by a healthcare professional or by the patient or a caregiver after appropriate training.
CIDP is a rare and progressive neuromuscular disorder characterized by weakness and numbness that can lead to disability, pain, and fatigue. The disorder has been linked to IgG autoantibodies.
Supportive Data
The efficacy, safety, and tolerability of HyQvia for CIDP were evaluated in the phase 3 randomized, double-blind, placebo-controlled ADVANCE-CIDP 1 study.
The study enrolled 122 adults with a confirmed diagnosis of CIDP who had remained on a stable dosing regimen of intravenous immunoglobulin (IVIG) therapy for at least 3 months prior to screening.
The primary endpoint was the proportion of patients who suffered a relapse — defined as an increase of ≥ 1 point relative to the presubcutaneous treatment baseline score in two consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scores obtained less than 7 days apart.
Patients were randomly allocated to HyQvia or placebo at the same dose and infusion frequency as their prior IVIG treatment (every 2, 3, or 4 weeks) for 6 months or until withdrawal or relapse.
Analysis of the primary endpoint demonstrated a statistically significant difference between the relapse rates in the HyQvia and placebo groups (14% vs 32%; P = .0314).
The 18.3% difference in relapse rate indicates that HyQvia was superior to placebo in preventing relapse of CIDP, the company noted in a news release.
In ADVANCE-CIDP 1 and ADVANCE-CIDP 3, the open-label extension study, the most common adverse reactions observed in > 5% of patients were local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremities.
"While it is considered the standard of care for maintenance treatment of adults with CIDP, IVIG infusions may be challenging for some patients and their caregivers," Lisa Butler, executive director, GBS-CIDP Foundation International, said in the news release.
"We're excited that this therapy could offer some adults with CIDP an alternative subcutaneous option that may address some of these challenges and help personalize treatment," Butler added.
Full prescribing information is available online.