Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today announced that Takeda received European Commission (EC) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme’s ENHANZE® drug delivery technology as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG). HYQVIA® also recently received U.S. Food and Drug Administration (FDA) approval as maintenance therapy for adults with CIDP.
HYQVIA® is the only FDA and now EC-approved combination of immunoglobulin (IG) and hyaluronidase for CIDP and is administered by facilitated subcutaneous infusion. For patients with CIDP, HYQVIA® can be infused up to once monthly (every two, three or four weeks). HYQVIA® can be administered by a healthcare professional or self-administered in the patient’s home after appropriate training.
“The demand for new personalized maintenance treatment options for patients with CIDP continues to grow, and we are pleased to partner with Takeda to expand the HYQVIA offering to Europe,” said Dr. Helen Torley, president and chief executive officer of Halozyme.
The centralized marketing authorization for HYQVIA® in CIDP is valid in all EU member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland.