Topline data were announced from a phase 3 trial evaluating the efficacy and safety of Hyqvia® (immune globulin infusion 10% [human] with recombinant human hyaluronidase) for the maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

The multicenter, placebo-controlled, double-blind ADVANCE-1 trial (ClinicalTrials.gov Identifier: NCT02549170) included 132 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. Patients were randomly assigned to receive either Hyqvia or placebo at the same dose and infusion frequency as their prior IVIG treatment for 6 months or until relapse. 

The primary endpoint was the proportion of patients who experienced a worsening of functional disability, defined as an increase of at least 1 point relative to the pre-subcutaneous treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment disability scores. 

Results showed that treatment with Hyqvia reduced CIDP relapse, with 9.7% of Hyqvia-treated patients experiencing relapse vs 31.4% of patients in the placebo group (P =.0045). The majority of patients received a 4-week dosing regimen of Hyqvia.

Patients who relapsed were offered IVIG treatment with Gamunex-C® for 6 months in the open-label rescue arm of the ADVANCE-2 trial. Patients who remained relapse free were offered to continue treatment with Hyqvia in the open-label extension ADVANCE-3 trial (ClinicalTrials.gov Identifier: NCT02955355).

“While the efficacy and safety of intravenous immunoglobulin therapy in CIDP is well-established, there is a substantial burden associated with chronic administration of therapies for patients with CIDP,” said Kristina Allikmets, Head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit. “There is a significant need for a treatment that is both efficacious and can be administered monthly at home or in the hospital with a reduced number of infusion sites and reduced administration duration and frequency. We are committed to bringing this therapy to people with CIDP as quickly as possible.”

Hyqvia is currently approved for the treatment of primary immunodeficiency in adults, including, but not limited to, common variable immunodeficiency, congenital or X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

The Company expects to submit a regulatory application for the CIDP indication sometime in 2022.

Reference

Takeda announces positive topline results from pivotal phase 3 clinical trial evaluating Hyqvia® for maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). News release. Takeda. Accessed July 21, 2022. https://www.businesswire.com/news/home/20220720005561/en/Takeda-Announces-Positive-Topline-Results-from-Pivotal-Phase-3-Clinical-Trial-Evaluating-HYQVIA%C2%AE-for-Maintenance-Treatment-of-Chronic-Inflammatory-Demyelinating-Polyradiculoneuropathy-CIDP