Baxter and Halozyme announced that the Food and Drug Administration has approved Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) for adult patients with primary immunodeficiency (PI).

Hyqvia is the first subcutaneous immune globulin (IG) treatment approved for PI that requires only one infusion every 3–4 weeks and one injection site per infusion to receive the full dose. The IG 10% component is prepared from large pools of human plasma consisting of at least 98% IgG, and contains a broad spectrum of antibodies that provides the therapeutic effect. The recombinant human hyaluronidase component increases dispersion and absorption of the Immune Globulin Infusion 10% (Human).

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Hyqvia is expected to launch in the coming weeks. It will be available in a dual vial unit of 2 single-use vials containing the active IG 10% and recombinant human hyaluronidase: 2.5g/200U, 5.0g/400U, 10.0g/800U, 20.0g/1600U, and 30.0g/2400U.

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