Simponi filed with EMA for Axial Spondyloarthritis-Janssen
Janssen announced that a Type II Variation has been filed with the European Medicines Agency seeking approval of Simponi (golimumab) for the treatment of severe active non-radiographic Axial Spondyloarthritis (nr-AxSpA). Nr-AxSpA is a form of Spondyloarthritis—chronic inflammatory diseases affecting the spine—in which the predominant symptom is back pain and stiffness. The application is supported by data from the Phase III GO-AHEAD trial, a MSD sponsored program conducted in collaboration with Janssen, which evaluated the efficacy and safety of Simponi compared with placebo in adults with active nr-AxSpA. Data from the GO-AHEAD study will be presented at the 2014 American College of Rheumatology Annual Meeting.
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