FDA Approves Baxter's HyQvia For Primary Immunodeficiency
By Cyndi Root
Baxter announced in a press release that the Food and Drug Administration (FDA) has approved HyQvia. The biologic treatment is indicated for adults with primary immunodeficiency (PI), a hereditary disorder wherein part of the immune system is either absent or not functioning properly. Baxter intends to market the drug in the coming weeks. The drug was co-developed with Halozyme Therapeutics.
Dr. Helen Torley, President and CEO of Halozyme, said, "Today's FDA approval of Hyqvia is a significant milestone for Halozyme, as it represents the first U.S. approved Biologics License Application which utilizes our rHuPH20 platform.”
HyQvia
HyQvia is already approved for PI and chronic lymphocytic leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections in several European countries, including Italy, Ireland, and Sweden. HyQvia is an immune globulin (IG) product, which consists of human immune globulin and Recombinant Human Hyaluronidase. The IG component is made from human plasma containing IgG, providing the therapeutic effect through broad spectrum antibodies. The hyaluronidase component increases dispersion and absorption of the IG.
The subcutaneous treatment is administered once a month, in contrast to other therapeutics that are administered intravenously weekly or bi-weekly. Additionally, HyQvia is administered at one injection site, and not at multiple sites like other treatments. Marcia Boyle, President and Founder of the Immune Deficiency Foundation, said, “Since each person with PI responds differently to treatment, having options that meet these individual needs is critically important.”
Halozyme’s rHuPH20 Platform
HyQvia utilizes Halozyme’s rHuPH20 platform. The ENHANZE Technology is a proprietary and patented delivery platform. The enzyme, recombinant human hyaluronidase (rHuPH20), degrades hyaluronan, a structural component of the human skin. The temporary degradation allows for subcutaneous injection of biologic treatments. The technology works with monoclonal antibodies, large therapeutic molecules (up to 200 nanometers), fluids, and small molecules. The effect of rHuPH20 is temporary, as the hyaluronan reconstitutes to normal density within several days.
Halozyme states that many treatments currently being injected intravenously are eligible to be subcutaneously injected. This method offers enhanced pharmacokinetics, extended product life, reduced costs, and improved patient convenience. Halozyme is actively seeking partners to develop the technology. Currently, the company is collaborating with Baxter, Hoffman-La Roche, and Pfizer.