Baxter, Halozyme Receive FDA Approval for Hyqvia
Baxter International Inc. and Halozyme Therapeutics, Inc., have received approval from the US Food and Drug Administration (FDA) for Baxter’s subcutaneous treatment, Hyqvia (immune globulin infusion 10% (human) with recombinant human hyaluronidase to treat adult patients with primary immunodeficiency.
Hyqvia is a product consisting of immune globulin Infusion 10% (human) (IG 10%) and recombinant human hyaluronidase (developed by Halozyme Therapeutics). The IG component, a 10% solution that is prepared from large pools of human plasma consisting of at least 98% IgG, contains a broad spectrum of antibodies and provides the therapeutic effect. The recombinant human hyaluronidase of Hyqvia increases dispersion and absorption of the immune globulin infusion 10% (human).
The companies report that 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 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 US in the coming weeks. It was approved in Europe in 2013 for adults with PI syndromes and myeloma or chronic lymphocytic leukemia 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.
In other news, Baxter received FDA approval for Rixubis [coagulation Factor IX (Recombinant)] for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B. Rixubis was the first recombinant factor IX (rFIX) approved for routine prophylaxis and control of bleeding episodes in the US for adults living with this chronic condition.