Centocor, Inc. and Schering-Plough Submit Application Requesting Approval of Golimumab in Europe for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

18.03.08 - 22:53 ... source : Schering-Plough

... HORSHAM, Pa. and KENILWORTH, N.J., March 18 /PRNewswire/ -- Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP - News) announced today that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The initial submission and Phase 3 development programs are unprecedented among anti-tumor necrosis factor (TNF)- alpha therapies, as they mark the first time that an MAA has been proposed for review inclusive of three unique disease states. Golimumab, Centocor's and Schering-Plough's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every f ...» Next (HTML)