HyQvia Approved for Chronic Inflammatory Demyelinating Polyneuropathy

The Food and Drug Administration (FDA) has approved HyQvia^® (immune globulin infusion 10% [human] with recombinant human hyaluronidase) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent  relapse of neuromuscular disability and impairment in adults.

The approval was based on data from the placebo-controlled ADVANCE-1 trial (ClinicalTrials.gov Identifier: NCT02549170) and a single-arm, open-label, extension study (ADVANCE-3 trial; ClinicalTrials.gov Identifier: NCT02955355).

The ADVANCE-1 study enrolled adult participants with CIDP who had remained on a stable dosing regimen of intravenous immunoglobulin therapy for at least 3 months prior to screening. Patients were randomly assigned to receive HyQvia (n=62) or placebo (n=70); all 132 patients were analyzed for safety and 122 participants were analyzed for efficacy. Mean duration of exposure was 5.3 months in the HyQvia group and 4.7 months in the placebo group. The mean monthly equivalent dose was 1.1g/kg. 

Findings showed a statistically significant difference in relapse rates indicating that HyQvia was superior to placebo in preventing relapse of CIDP (14% vs 32.2%, respectively, P =.0314). The treatment difference was -18.3% (95% CI, -32.1%, -3.1%). Separation from placebo was observed as early as week 4.

The study also evaluated the effect of HyQvia vs placebo on activities of daily living (as measured by the Rasch-built Overall Disability Scale centile score). The least squares mean changes were reported to be -1.2 in the HyQvia group and -6.3 in the placebo group (treatment difference, 5.1).

The phase 3b extension study evaluated the long-term effects of HyQvia and was open to patients who completed ADVANCE-1 without CIDP worsening or relapse. During the interim study period, the proportion of patients who developed relapse was 8.8% (n=5/57). The 6-month relapse rate was reported to be 1.6%. 

The most common adverse reactions reported with HyQvia were local reactions, headache, pyrexia, nausea, fatigue, erythema, pruritus, increased lipase, abdominal pain, back pain, and pain in extremity.

HyQvia is available in a dual vial unit of 2 single-use vials containing the active IG 10% and recombinant human hyaluronidase: 2.5g/200U, 5g/400U, 10g/800U, 20g/1600U, and 30g/2400U. The treatment is administered subcutaneously.