SAN DIEGO, Calif. — 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.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme’s commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including Hylenex® and XYOSTED® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.
Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.
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