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FDA Approves Takeda’s HYQVIA with ENHANZE Technology

Halozyme's ENHANZE drug delivery facilitates dispersion and absorption of large IG volumes subcutaneously.

By: Kristin Brooks

Managing Editor, Contract Pharma

Takeda received U.S. 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). 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.
 
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, infusion center or at a patient’s home. 
 
“We are pleased that Takeda continues to expand the indications for HYQVIA®, providing a new personalized maintenance treatment option for adult patients with CIDP,” said Dr. Helen Torley, president and chief executive officer of Halozyme.
 

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