EMA Advisory Committee OKs New Use for J&J’s Simponi
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the use of Janssen Biologics B.V. ‘s subcutaneous Simponi (golimumab) in combination with methotrexate (MTX) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in children with a body weight of at least 40 kg, who have responded inadequately to previous therapy with MTX.
Based on the CHMP’s positive opinion, a final decision from the European Commission is expected in the coming months.
Simponi is 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. It is approved in more than 85 countries for rheumatologic indications, including rheumatoid arthritis (RA), ankylosing spondylitis, and psoriatic arthritis. In the European Union (EU), it eceived European Commission approval in October 2009 for the treatment of moderate-to-severe, active RA 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 in adults. In June 2015, it received European Commission approval for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation. It is available either through the SmartJectÂ® autoinjector/prefilled pen or a prefilled syringe as a subcutaneously administered injection.
Janssen Biotech, Inc. discovered and developed Simpoini and markets the product in the United States. The Janssen Pharmaceutical Companies market Simpoini n 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 Simponit to Mitsubishi Tanabe Pharma Corporation and has retained co-marketing rights in those countries.
Source: Johnson & Johnson