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news.The FDA has approved Baxter Healthcare Corporation's Gammagard Liquid 10% solution for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity.
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Primary immunodeficiency is a group of genetic disorders in which the immune system fails to produce adequate amounts of antibodies, thereby predisposing individuals to increased risk of infection.
The ready-to-use, sterile preparation of Gammagard Liquid 10% eliminates the need for reconstitution and its high concentration, compared to 5% concentrations, allows for a reduction in the length of infusion, reducing the infusion volume and saving time for both patients and healthcare professionals.
The approval was based on a phase III, multicenter study of 61 patients between the ages of 6 and 72 years who were treated with 300 to 600mg/kg every 21 to 28 days for 12 months. In this study, no validated acute serious bacterial infections occurred in any of the treated subjects.
Baxter intends to launch Gammagard Liquid 10% in five vial sizes, which will allow for tailored dosing and help reduce waste. The company plans to launch the plasma-based therapy in the fourth quarter of this year.