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Ankylosing Spondylitis

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

Published in Medical Letter on the CDC and FDA, April 6th, 2008

Centocor, Inc. and Schering-Plough Corporation (NYSE:SGP) announced 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...

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