Positive top-line Phase III results for Hyqvia

Japan’s largest drugmaker Takeda (TYO: 4502) has announced that ADVANCE-1, a randomized, placebo-controlled, double-blind Phase III clinical trial evaluating Hyqvia (immune globulin Infusion 10% (human) with recombinant human hyaluronidase) for the maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), met its primary endpoint.

Top-line data show that Hyqvia reduced relapse of neuromuscular disability and impairment when used as a maintenance therapy for CIDP, supporting its potential as a facilitated subcutaneous immunoglobulin (fSCIG) solution that could allow for monthly infusion for many CIDP patients. Analyses from ADVANCE-1 are ongoing, and the company anticipates disclosing additional data in an upcoming medical forum.

The pivotal ADVANCE-1 clinical trial evaluated the efficacy, safety and tolerability of Hyqvia in 132 adult patients with CIDP who had been on a stable dosing regimen of intravenous immunoglobulin (IVIG) therapy for at least three months prior to infusion. Analysis of the primary endpoint shows that Hyqvia, when administered at the same dose and dosing interval as the patient’s previous IVIG, reduced CIDP relapse as compared to placebo [9.7% versus 31.4%, respectively; p-value = 0.0045], as measured by Inflammatory Neuropathy Cause and Treatment (INCAT). The majority of patients in the study received a four-week dosing regimen of Hyqvia.