Gammaplex 10% Gets FDA Approval
Bio Products Laboratory announced that the Food and Drug Administration (FDA) has approved Gammaplex 10% (immune globulin intravenous [human], 10% liquid) for the treatment of primary immunodeficiency (PI) and chronic immune thrombocytopenic purpura (ITP) in adults.
Specific conditions include the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Gammaplex 10% contains an immune globulin G (IgG) concentration of 100g/L and is stabilized with glycine.
The FDA approval was based on data from a 2-phase crossover bioequivalence study comparing Gammaplex 10% vs. Gammaplex 5% in adults with PI (n=33). Bioequivalence between the two products—the primary endpoint—was met and trough levels of IgG were well maintained throughout the study This is the first study to directly compare the 10% and 5% IVIG products for the treatment of PI.
When the infusion rates were increased incrementally for both Gammaplex 5% and 10%, researchers found no difference in the safety and tolerability between both products.
The most common adverse effects in adults receiving Gammaplex 10% were headache, migraine, and pyrexia. The safety of Gammaplex 10% has not been established in patients with ITP, however Gammaplex 5% has been studied in patients with ITP, and it is anticipated that the safety profile is similar for both formulations.
Gammaplex 10% will be available as a liquid solution containing 5g in 50mL, 10g in 100mL, and 20g in 200mL in single-use bottles.
For more information call (844) 4BPLUSA or visit Gammaplex.com.