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FDA Approves Hyqvia (Immune Globulin Infusion 10%) for Adults With Primary Immunodeficiency
The FDA has given the green light to Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase, Baxter International/Halozyme Therapeutics), a subcutaneous treatment for adult patients with primary immunodeficiency (PI).
Hyqvia is the first subcutaneous immune globulin treatment approved for PI patients with a dosing regimen requiring only one infusion up to once per month (every 3 to 4 weeks) and one injection site per infusion to deliver a therapeutic dose of immune globulin. Most PI patients receive intravenous infusions in a physician’s office or an infusion center, and current subcutaneous immune globulin treatments require weekly or biweekly treatment with multiple infusion sites per treatment.
Hyqvia is expected to be launched in the U.S. in the coming weeks. The treatment is currently prescribed in several European countries for adults (18 years of age or older) with PI syndromes and myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent infections.
The immune globulin component of Hyqvia — a 10% solution that is prepared from large pools of human plasma consisting of at least 98% immune globulin G (IgG) — contains a broad spectrum of antibodies and provides the treatment’s therapeutic effect. The recombinant human hyaluronidase in Hyqvia increases the dispersion and absorption of the immune globulin infusion 10% (Human).
Source: Baxter; September 12, 2014.