Bayer HealthCare LLC, Biological Products Division through its Canadian affiliate Bayer Inc has received approval from Health Canada for Gamunex, Immune Globulin Intravenous (Human), 10%, its new and advanced IGIV product. Gamunex is approved for use in Canada for the treatment of idiopathic thrombocytopenic purpura, primary immune deficiencies, allogeneic bone marrow transplantation, and pediatric HIV infection. Gamunex offers a wide range of patient benefits, including rapid infusion, excellent tolerability, and room temperature storage.
Gamunex is the first new IGIV product to be approved in Canada in several years and maintains the excellent product profile of Bayer BP's market-leading Gamimune N, 10%, Immune Globulin Intravenous (Human), 10%. Building on more than 20 years of continuous commitment to product improvement, Bayer BP used a "clean sheet" approach to develop an optimal production process for Gamunex, which features an innovative caprylate/chromatography purification process that improves product quality and reliability. The large, multinational clinical development program demonstrated clinical efficacy, safety, and tolerability of Gamunex.
The most common side effects noted during clinical trials included: headache, vomiting, fever, nausea, rash, and back pain.
"The first worldwide approval of Gamunex marks a major milestone in bringing our next generation IGIV to market, and will allow the patients who depend on our products to spend less time suffering from disease and more time living," said Dr. Gunnar Riemann, president, Bayer Biological Products Division. "The approval in Canada, and our anticipated approval in the United States, will allow us to implement our phased global launch strategy with an initial focus on North America, the largest IGIV market in the world."
Bayer BP has been a major supplier of IGIV in Canada for many years with its current product, Gamimune N 10%, Immune Globulin Intravenous (Human), 10%, a highly concentrated liquid formulation. It is anticipated that Gamunex will be available to patients everywhere in Canada in early 2004.