Biopharmaceutical company Takeda (TSE:4502) (NYSE:TAK) said on Tuesday that it has secured US Food and Drug Administration (FDA) approval for HYQVIA (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase) as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults, to prevent the relapse of neuromuscular disability and impairment.

Originally approved in 2014 for primary immunodeficiency (PI) treatment in adults, HYQVIA's scope has since expanded to include children aged 2-16.

Offering a unique combination of immunoglobulin (IG) and hyaluronidase, HYQVIA's facilitated subcutaneous immunoglobulin (SCIG) infusion is adaptable, allowing administration every two, three or four weeks. The hyaluronidase component aids dispersion and absorption, enabling healthcare professionals to administer it in medical offices, infusion centres or patients' homes. Moreover, patients or caregivers can undergo training for self-administration.

This latest FDA approval is based on results from studies which showed a statistically significant relapse rate reduction favouring HYQVIA over placebo at six months.

CIDP, a rare neuromuscular disorder, manifests as progressive, symmetric symptoms like limb weakness, tingling and reflex loss. CIDP diagnosis challenges, coupled with IVIG treatment complexities, underscore the significance of HYQVIA's approval.

HYQVIA is now available as a maintenance therapy for adult patients with CIDP in the United States. In December 2023, Takeda announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA as maintenance therapy in patients with CIDP after stabilisation with IVIG. The European Commission will consider the CHMP positive opinion when determining the potential marketing authorisation for HYQVIA for CIDP in the European Union.