HyQvia Treatment for Chronic Inflammatory Demyelinating Polyneuropathy Receives FDA Approval

HyQvia (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase; Takeda, Cambridge, MA) has been approved by the Food and Drug Administration (FDA) as a maintenance treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). HyQvia is approved as a subcutaneous infusion for administration up to once monthly to prevent the relapse of neuromuscular disability and impairment in adults. In 2014, the FDA granted HyQvia its first approval as a treatment for primary immunodeficiency (PI) in adults, which was expanded in 2023 to include children aged 2 to 16 years.

The FDA approval for the use of HyQvia in CIDP is based on positive data from the phase 3 ADVANCE-CIDP 1 clinical trial (NCT02549170) and its open-label extension (OLE) study, ADVANCE-CIDP 3 (NCT02955355). ADVANCE-CIDP 1 was a randomized, double-blind, placebo-controlled study whose efficacy evaluation included 122 adults with a confirmed diagnosis of CIDP who, for ≥3 months before screening, remained on a stable dosing regimen of intravenous immunoglobulin (IVG). The primary outcome measures of ADVANCE-CIDP 1 were relapse rate at epoch 1 (week 32) and responder rate at epoch 2 (≤6 months after epoch 1). In the OLE 2, safety endpoints including number of patients experiencing adverse events (AEs), serious adverse events (SAEs), and adverse reactions (ARs) were assessed as primary outcome measures.

In the reported results of the clinical trial, the relapse rates for people who received HyQvia (n=57, 14.0%) were significantly lower than for those who received placebo (n=65, 32.3%). The treatment difference was -18.3% (2-sided 95% CI, -32.1% to -3.1%), demonstrating that HyQvia was efficacious in preventing relapse of CIDP. The most common adverse reactions observed in >5% of study participants included local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritis, increased lipase, abdominal pain, back pain, and pain in extremity.

“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,” said Lisa Butler, Executive Director, GBS-CIDP Foundation International. “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.”

HyQvia’s label contains a boxed warning for thrombosis.