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news.Baxter International has received the US Food and Drug Administration (FDA) approval for its subcutaneous administration of gammagard liquid 10% [Immune Globulin Infusion (Human)] for patients with primary immunodeficiency (PI).
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Gammagard liquid is indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years of age or over.
Baxter gammaglobulin trials medical director Richard Schiff said the FDA approval of a subcutaneous route of administration for gammagard liquid offers PI patients the option to administer the liquid either intravenously or subcutaneously, depending on their individual needs.
"The clinical data of gammagard liquid, our subcutaneous clinical trial in patients with PI demonstrated efficacy consistent with that seen in other clinical studies of intravenous and subcutaneous immune globulin," Schiff said.