FDA Approves Baxter’s HYQVIA for Treatment of PI
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved HYQVIA (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase), Baxter’s subcutaneous treatment for adult patients with primary immunodeficiency (PI). HYQVIA is the first subcutaneous immune globulin (IG) treatment approved for PI patients with a dosing regimen requiring only one infusion up to once per month (every three to four weeks) and one injection site per infusion to deliver a full therapeutic dose of IG. “The availability of HYQVIA has a significant impact on the treatment of PI, allowing for effective delivery of a full therapeutic dose of IG less frequently than other subcutaneous treatments (up to once a month), while maintaining the efficacy, safety and tolerability profile that is most important for patients,” said Ludwig Hantson, PhD, president of Baxter BioScience. “This approval highlights the support of the patient community for new treatment options.”
HYQVIA was approved in Europe in 2013 for adults 18 years and older with PI and myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent infections. It is currently available in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.
