July 18, 2013 /PRNewswire/ — Janssen Biotech, Inc. announced today the U.S. Food and Drug Administration (FDA) approval of SIMPONI® ARIATM (golimumab) for infusion for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. SIMPONI ARIA, the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible therapy, has been shown to significantly improve signs and symptoms and physical function, and inhibit the progression of structural damage. The SIMPONI ARIA dose regimen is 2 mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks thereafter. The infusion is given over a 30-minute period, providing a short infusion time for patients. Approximately 1.3 million people in the United States are living with RA,[i] a chronic, systemic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability.[ii]
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Golimumab (CNTO 148)is a human monoclonal antibody which is used as an immunosuppressive drug and marketed under the brand name Simponi. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory moleculeand hence is a TNF inhibitor.
Golimumab was developed by Centocor and is approved in Canadaand the United Statesas a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.Golimumab is pending FDA approval for Ulcerative Colitis.
In the same year, Johnson & Johnson, the parent company of Centocor, also received an approval from European Medicines Agency (EMEA) for the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.Golimumab is marketed by Merck & Co, Inc. in Europe, pending final arbitration between J&J and Merck
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