FDA Approves Gammaplex 10% to Treat Adult PI and ITP Patients
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved Bio Products Laboratory’s (BPL) 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 immune globulin, Gammaplex 5%, but has an IgG concentration of 100 g/L and is stabilized with glycine.
Approval was based on a Phase II crossover bioequivalence study comparing Gammaplex 10% and Gammaplex 5% in 33 adult patients with PI. In the study, both Gammaplex 10% and Gammaplex 5% infusion rates were increased incrementally at 15-minuteintervals if tolerated. 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 percent of infusions. The mean infusion time for Gammaplex 10% was one hour and 51 minutes, which was 57 minutes faster than Gammaplex 5%. The most common adverse reactions were headache (12.5 percent), migraine (6.3 percent) and pyrexia (6.3 percent). No serious product-related adverse effects occurred.
While the safety of Gammaplex 10% has not yet been established in ITP patients, Gammaplex 5% has been studied, and it is anticipated that the safety profile for both formulations are comparable
References
- FDA Approves Bio Products Laboratory’s Gammaplex 10% for Treatment of Primary Immunodeficiency and Chronic Immune Thrombocytopenic Purpura. Bio Products Laboratory press release, Feb. 7, 2017. Accessed at www.prnewswire.com/news-releases/fda-approves-bio-products-laboratorys-gammaplex-10-for-treatment-of-primary-immunodeficiency-and-chronicimmune-thrombocytopenic-purpura-300403379.html.
