Halozyme-Takeda OKd on Maintenance Therapy in Chronic Inflammatory Demyelinating Polyneuropathy

 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Takeda received U.S. Food and Drug Administration (FDA) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme's ENHANZE® drug delivery technology for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults. HYQVIA® was first granted FDA approval in 2014 for the treatment of primary immunodeficiency (PI) in adults, which has since been expanded to include children 2-16 years old.1 

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 ENHANZE®, which facilitates the dispersion and absorption of large IG volumes in the subcutaneous space. 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.

https://www.prnewswire.com/news-releases/halozyme-announces-takeda-receives-fda-approval-for-hyqvia-co-formulated-with-enhanze-as-maintenance-therapy-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-302035497.html