The European Medicines Agency (EMA) has approved the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The commercial product is produced in a recombinant cell line cultured by continuous perfusion. The golimumab-secreting clone was selected after being assayed for human light and heavy chains and TNFα-binding.
The antibody was isolated from a hybridoma clone produced by transgenic mice immunized with human TNFα. Golimumab binds to both soluble and transmembrane forms of TNFα. In Japan, Indonesia and Taiwan, distribution rights are held by Mitsubishi Tanabe Pharma Corporation. In Europe, Russia and Turkey, Simponi distribution rights are held by Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific. (formerly Centocor Biotech, Inc.) which also markets the product in the United States. Golimumab was developed by Janssen Biotech, Inc. It is on the World Health Organization's List of Essential Medicines. Profound reduction in C-reactive protein (CRP) levels, interleukin (IL)-6, intercellaular adhesion molecules ( ICAM)-1, matrix metalloproteinase (MMP)-3, and vascular endothelial growth factor (VEGF) demonstrates golimumab as an effective modulator of inflammatory markers and bone metabolism. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule and hence is a TNF inhibitor.
Golimumab is a human monoclonal antibody which is used as an immunosuppressive medication and sold under the brand name Simponi.
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