Takeda Reports Topline Results from Pivotal Phase 3 HyQvia Study in CIDP

Takeda reported positive topline results from its ADVANCE-1 study of HyQvia for the maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy, which showed the experimental therapy met its primary endpoint.

Topline data show that HyQvia reduced relapse of neuromuscular disability and impairment when used as a maintenance therapy for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Analyses from ADVANCE-1 are ongoing, and the company anticipates disclosing additional data in an upcoming medical forum.

CIDP is a chronic, acquired, immune-mediated condition affecting the peripheral nervous system that is characterized by progressive, symmetric weakness in distal and proximal limbs and impaired sensory function in extremities. Because it is a slow progressing or relapsing disease, accurate diagnosis can take years to make.

HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins and approved in the United States to treat adult patients with primary immunodeficiency (PI). It is also approved in the European Union as a replacement therapy in adults, children, and adolescents with PI and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or low serum IgG levels.

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 percent vs 31.4 percent], as measured by Inflammatory Neuropathy Cause and Treatment (INCAT). The majority of patients in the study received a four-week dosing regimen of HyQvia.

“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 and 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.”

In topline analyses of ADVANCE-1, HyQvia showed a favorable safety profile, further supporting its use as a maintenance therapy for CIDP. Of the 62 patients treated with HyQvia, the majority of treatment-related adverse events were reported as mild or moderate. No new safety risks were reported with HyQvia.

Takeda intends to submit applications for HyQvia to regulatory authorities in the United States and European Union in fiscal year 2022.

Author: Rare Daily Staff