European Commission Approves Takeda’s Hyqvia as Maintenance Therapy in Patients with CIPD

Rare Daily Staff

The European Commission approved Takeda’s Hyqvia as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy after stabilization with intravenous immunoglobulin therapy.

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare, acquired, immune-mediated neuromuscular disorder affecting the peripheral nervous system. It is typically characterized by progressive, symmetric symptoms such as weakness, tingling, or loss of feeling in distal and proximal limbs, loss of reflexes and difficulty walking. Because its symptoms may overlap with other rare, neuromuscular conditions, CIDP is often misdiagnosed.

Hyqvia is the first and only approved combination of immunoglobulin (IG) and hyaluronidase, which makes it a facilitated subcutaneous immunoglobulin (SCIG) infusion. Because it is delivered subcutaneously, Hyqvia can be administered by a healthcare professional in a medical office, infusion center or at a patient’s home. In addition, it can be self-administered after appropriate patient or caregiver training.

“Following the FDA approval of the Hyqvia CIDP indication in January 2024, the EC’s approval of Hyqvia for CIDP is a critical step towards giving people in the EU living with CIDP access to a maintenance treatment with proven efficacy that can be administered up to once monthly, at-home or in-office,” said Kristina Allikmets, senior vice present and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit.

The approval is based on data from the pivotal phase 3 ADVANCE-CIDP 1 trial, which was a multicenter, placebo-controlled, double-blinded study that evaluated the efficacy and safety of Hyqvia as a maintenance therapy to prevent relapse in patients with CIDP. The global study included 132 adults with a confirmed diagnosis of CIDP who had remained on a stable dosing regimen of IVIG therapy for at least three months prior to screening. Results showed a clinically significant reduction in CIDP relapse rate with Hyqvia versus placebo of 15.5 percent in the Hyqvia and 31.7 percent in the placebo groups. The treatment difference was -16.2, favoring Hyqvia over placebo.

While adverse events (AEs) were more frequent with Hyqvia (79.0 percent of patients) than placebo (57.1 percent), severe and serious AEs were less common. The majority of AEs were mild or moderate, local, did not require suspension of infusions, and resolved without sequelae. The most common (reported in >5 percent of patients) causally related AEs included headache and nausea, as well as local AEs including infusion site pain, erythema, pruritis, and edema. Overall, the safety profile observed in the ADVANCE-CIDP 1 trial was generally consistent with the existing EU Summary of Product Characteristics.

The centralized marketing authorization for Hyqvia in CIDP is valid in all EU member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland. Hyqvia first received approval from the EC for the treatment of primary immunodeficiency in 2013 as well as secondary immunodeficiency in 2020.

Photo: Kristina Allikmets, senior vice present and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit.