FDA grants approval for Bayer's Gamunex
Bayer HealthCare Biological Products Division (BP) has received approval from the US FDA for Gamunex, its immunoglobulin intravenous (IGIV) product for patients with compromised immune systems.
Bayer HealthCare Biological Products Division (BP) has received approval from the US FDA for Gamunex, its immunoglobulin intravenous (IGIV) product for patients with compromised immune systems.
This new product, which was recently also approved also in Canada, introduces a breakthrough purification process, called caprylate/chromatography.
To support the approval for Gamunex, Bayer BP undertook an unprecedented licensure-relevant clinical trial programme, including the largest ever series of trials on patients with compromised immune systems. The study results demonstrated the excellent efficacy, safety, and tolerability of Gamunex.
Bayer BP currently manufactures and distributes Gamimune N 10%/Polyglobin 10%, Immune Globulin Intravenous (Human) 10%, which is approved for various conditions such as primary immune deficiency, provides patients with the newest treatment available pediatric AIDS, and bone marrow transplants.
'The approval of Gamunex in the US provides patients with the newest treatment available,' said Dr Gunnar Riemann, president, Bayer BP. 'Approval in the US and Canada allows us to implement our phased global launch strategy, with an initial focus on North America, the largest IGIV market in the world.'