FDA approves Takeda’s HYQVIA to treat CIDP as maintenance therapy

Takeda announced that the U.S. Food and Drug Administration FDA, has approved HYQVIA or Immune Globulin Infusion 10%… Human…with Recombinant Human Hyaluronidase, for the treatment of chronic inflammatory demyelinating polyneuropathy CIDP as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults. HYQVIA first received approval in the U.S. in 2014 for the treatment of primary immunodeficiency PI) in adults, which has since been expanded to include children 2-16 years old. 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 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. 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 “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.”