EC OKs New Use for J&J’s Simponi
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Janssen Biologics B.V. reports that the European Commission (EC) has approved Simponi (golimumab) for treating adults with severe active non-radiographic axial spondyloarthritis (nr-AxSpA) with objective signs of inflammation (OSI), as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). The EC approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in May 2015 recommending the use of Simponi for this indication. Nr-AxSpA is a form of spondyloarthritis—a chronic inflammatory disease affecting the spine—in which the predominant symptom is back pain and stiffness.

This is the fifth indication approved for Simponi, a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. Simponiis approved in 85 countries for rheumatologic indications, including the European Union (EU), where it received European Commission approval in October 2009 for the treatment of moderate-to-severe, active rheumatoid arthritis in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis alone or in combination with methotrexate and for the treatment of severe, active ankylosing spondylitis. In September 2013, it received European Commission approval for the treatment of moderately to severely active ulcerative colitis.

Janssen Biotech, Inc. discovered and developed Simponi and markets the product in the United States. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to Simponi to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. In Japan, Indonesia and Taiwan, Janssen Biotech, Inc. licenses distribution rights to Simponi to Mitsubishi Tanabe Pharma Corporation and has retained co-marketing rights in those countries.

Source: Johnson & Johnson

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