Takeda's Hyqvia Bags US FDA Nod for Maintenance Therapy in Adults

Takeda announced that Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] has been approved by the US Food and Drug Administration (FDA) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability or impairment in adults. Hyqvia originally got approval in the United States in 2014 for the treatment of primary immunodeficiency (PI) in adults, and it has recently been expanded to include children aged 2 to 16.

Hyqvia is the only FDA-approved combination of immunoglobulin (IG) and hyaluronidase, which makes it a facilitated subcutaneous immunoglobulin (SCIG) infusion. For adults with CIDP, Hyqvia can be infused up to once monthly (every two, three or four weeks) due to the hyaluronidase component, which facilitates the dispersion and absorption of large IG volumes in the subcutaneous space between the skin and the muscle, as per pharmabiz. 

Hyqvia, which is injected subcutaneously, can be administered by a healthcare practitioner in a medical office, infusion center, or at a patient's home. Furthermore, it can be self-administered with proper patient or caregiver training.

“With the FDA approval of Hyqvia for CIDP, which builds on our expertise in rare neuroimmunological and neuromuscular disorders, we can now offer a personalized maintenance treatment option for adults with this debilitating disease,” said Giles Platford, president of Takeda’s Plasma-Derived Therapies Business Unit. “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."