Bayer HealthCare LLC has received approval from the U.S. Food and Drug Administration (FDA) for Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, its new and advanced immunoglobulin intravenous (IGIV) product. The approval of Gamunex in the United States, along with the recent approval in Canada, marks a major milestone in Bayer BP's more than 20 years of continuous commitment to improving product quality and reliability.
Each vial of IGIV contains antibodies purified from the donated blood plasma of thousands of people. These antibodies are essential as a life-saving therapy for patients with certain conditions that compromise their immune system. Because the protein structure of these antibodies is so fragile, the specifics of the manufacturing process, such as Bayer BP's Caprylate/Chromatography purification, have a direct impact on the quality of an IGIV product. As this treatment represents a life-saving therapy for patients with compromised immune systems, a high quality product is critical.
"Gamunex advances treatment for individuals with compromised immune systems," said Dr. Ronald Sacher, professor, Internal Medicine and Pathology, and director, Hoxworth Blood Center, University of Cincinnati Medical Center. "Bayer BP's strong clinical data provides confidence in the proven efficacy of Gamunex without compromising safety and excellent tolerability. I believe this demonstrates not all IGIVs are the same."