FDA approves HyQvia for treatment of Primary Immunodeficiency- Baxter

Baxter International Inc. and Halozyme Therapeutics, Inc. announced that the FDA has approved Baxter's subcutaneous treatment for adult patients with Primary Immunodeficiency (PI), HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]. 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 majority of PI patients today receive intravenous infusions in a doctor's office or infusion center, and current subcutaneous IG treatments require weekly or bi-weekly treatment with multiple infusion sites per treatment.

Baxter expects to launch HyQvia in the U.S. in the coming weeks. HyQvia was approved in Europe in 2013 for adults (=18 years) with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections. It is currently being prescribed in several European countries, including Germany , Netherlands , Sweden , Norway , Denmark , Ireland and Italy.