Takeda has received approval from the US Food and Drug Administration (FDA) for HYQVIA [immune globulin infusion 10% (human) with recombinant human hyaluronidase] to treat chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
It is indicated for maintenance therapy for the prevention of the relapse of this neuromuscular disability and impairment.
The approval marks an expansion of HYQVIA's indication in the US. The drug was initially approved in 2014 for primary immunodeficiency.
The approval was subsequently expanded to include the treatment of children aged two to 16 years.
A combination of immunoglobulin (IG) and hyaluronidase, HYQVIA is the only FDA-approved facilitated subcutaneous immunoglobulin infusion for CIDP.
It can be administered subcutaneously up to once monthly, offering a flexible dosing schedule for adults with this immune-mediated neuromuscular disorder.
The FDA's decision is supported by data from the ADVANCE-CIDP 1 clinical trial, a randomised, placebo-controlled double-blinded study, and the ADVANCE-CIDP 3 extension study.
The studies assessed HYQVIA's safety and efficacy as a maintenance therapy in adult CIDP patients.
The primary endpoint analysis from the ADVANCE-CIDP 1 study showed a significant reduction in relapse rates with HYQVIA versus placebo.
Local reactions, fever, headache, fatigue and nausea were the most frequently reported adverse reactions.
In 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended HYQVIA for approval as a CIDP maintenance therapy in the European Union.
The European Commission will review this recommendation for granting potential marketing authorisation.
Takeda plasma-derived therapies business unit president Giles Platford stated: “With the FDA approval of HYQVIA for CIDP, which builds on our expertise in rare neuroimmunological and neuromuscular disorders, we can now offer a personalised maintenance treatment option for adults with this debilitating disease.
“Research and clinical experience have shown that IG therapy is effective as maintenance treatment in adults with CIDP, and we hope that this approval for HYQVIA is the first of several around the world as we strive to deliver our broad and diverse IG portfolio to more people with complex neuroimmunological diseases.”
