FDA approval for Gamunex; first new immunoglobulin intravenous product in a decade
LEVERKUSEN, GERMANY, August 28, 2003 -- Bayer HealthCare LLC, Biological Products Division (Bayer BP) has received approval from the FDA for Gamunex [immune globulin intravenous (human), 10% caprylate/chromatography purified), its new and advanced immunoglobulin intravenous (IGIV) product.
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, M.D., 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."
In a survey conducted in June 2003 by the Immune Deficiency Foundation, Americans with primary immunodeficiency (PI)* diseases, the major licensed indication for IGIV, expressed a desire for safe, convenient, and reliable products that offered enhanced efficacy and excellent tolerability. These survey findings validate Bayer BP's commitment to develop a new and differentiated, next-generation IGIV product that meets the changing needs of both patients and the health care professionals who treat them.
As part of this commitment, Bayer BP initiated the largest and most rigorous clinical trials program in IGIV history to support FDA approval of Gamunex, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified. The PI study results demonstrate the excellent efficacy, safety, and tolerability of Gamunex, with patients in the Gamunex group experiencing a significant reduction in annual validated infection rates.
Gamunex is claimed to offer an important life-saving, usually life-long, treatment for thousands of patients with PI, a group of conditions caused by genetic defects in the immune system. Gamunex also is indicated for the acute and chronic treatment of idiopathic thrombocytopenia purpura (ITP), an autoimmune condition characterized by a low platelet count, leading to occasional life-threatening bleeding episodes. The most common side effects noted during clinical trials included: headache, vomiting, fever, nausea, rash and back pain.
Gamunex will be available in the United States later this fall, through traditional product distribution channels.
For additional information on Gamunex, see Full Prescribing Information at www.gamunex.com
Source: Bayer BP www.bayerbiologicals.com
Posted: August 2003