FDA approves Gammaplex 10% (immune globulin intravenous [human], 10% liquid) for primary immunodeficiency and chronic immune thrombocytopenic purpura- Bio Products Lab

Bio Products Laboratory announced that the 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. Gammaplex 10% is made with the same process as BPL's previously approved intravenous immunoglobulin (IVIG) treatment, Gammaplex 5% (immune globulin intravenous [human], 5% liquid). Gammaplex 10% is more concentrated than Gammaplex 5%, with an immune globulin G (IgG) concentration of 100g/L, and is stabilized with glycine.

The approval was based on a two-phase, crossover bioequivalence study comparing Gammaplex 10% and Gammaplex 5% in 33 adult patients with PI. The primary endpoint of bioequivalence between the products was achieved and trough levels of IgG were well maintained throughout the study. This study is the first direct comparison of 10% and 5% IVIG products in the treatment of PI. In the study both Gammaplex 10% and Gammaplex 5% infusion rates were increased incrementally at 15-minute intervals if tolerated by the subject. No notable differences were observed in the safety and tolerability between the products and the Gammaplex 10% infusion rate was increased per the prescribed infusion schedule to maximum infusion rate in 96% of infusions. The mean infusion time for Gammaplex 10% in adult patients was 1 hour and 51 minutes, which was 57 minutes faster than Gammaplex 5%. The most common adverse reactions in adult subjects receiving Gammaplex 10% in the PI clinical trial were headache (12.5% of subjects), migraine (6.3%), and pyrexia (6.3%). There were no serious product-related adverse reactions in the PI clinical trial.