Japan - Takeda (TSE: 4502/ NYSE: TAK) today announced that the European Commission (EC) approved HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).

Takeda previously announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 15, 20231 and approval as a maintenance therapy for adults with CIDP by the U.S. Food and Drug Administration on January 16, 2024.2

As the first and only facilitated subcutaneous immunoglobulin (fSCIG) for CIDP, HYQVIA offers the potential for patients to infuse up to once monthly (every two, three or four weeks), as the hyaluronidase component facilitates the dispersion and absorption of large immunoglobulin (IG) volumes in the subcutaneous space between the skin and the muscle. HYQVIA can be administered by a healthcare professional or self-administered in the comfort of a patient's own home after appropriate training.3

'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. 'This expanded indication for HYQVIA also reflects Takeda's commitment to bring the benefits of our immunoglobulin therapies to people with neuroimmunological disorders and provide treatment options that have the potential to positively impact their lives and elevate the standard of care.'

CIDP is an 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 the extremities.4 The role of IG therapy for this rare, debilitating and slowly progressing or relapsing disease has been well-established5 and is considered a standard of care for this complex and heterogeneous condition in guidelines from the European Academy of Neurology and Peripheral Nerve Society due to its broad immunomodulatory and anti-inflammatory effects.6

This 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 15.5% (95% CI: 8.36, 26.84) in the HYQVIA and 31.7% (95% CI: 21.96, 43.39) in the placebo groups. The treatment difference was -16.2 (95% CI: -29.92, -1.27), favoring HYQVIA over placebo.3

While adverse events (AEs) were more frequent with HYQVIA (79.0% of patients) than placebo (57.1%), severe (1.6% vs 8.6%) and serious AEs (3.2% vs 7.1%) 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% of patients) causally related AEs included headache and nausea, as well as local AEs including infusion site pain, erythema, pruritis, and edema. 7 Overall, the safety profile observed in the ADVANCE-CIDP 1 trial was generally consistent with the existing EU Summary of Product Characteristics (SmPC).3

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 (PID) in 2013 as well as secondary immunodeficiency (SID) in 2020.8

About HYQVIA

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (IG) and is approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents with primary immunodeficiency (PI) and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of

(C) 2024 Electronic News Publishing, source ENP Newswire