Janssen Biologics B.V. (Janssen) announced today 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.  While patients with nr-AxSpA may not initially present with evidence of structural damage to the joints, many will progress to having some degree of spinal fusion (e.g., ankylosing spondylitis), particularly young males.

“We believe that this new application for Simponi in the European Union shows the potential role this anti-TNF-alpha therapy may play as a treatment option for people living with this debilitating inflammatory disease,” said Newman Yeilding, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC.  “We look forward to collaborating with the European Medicines Agency to progress Simponi as a treatment for people living with non-radiographic axial spondyloarthritis.”

The application is supported by data from the Phase 3 GO-AHEAD trial, a MSD- (known as Merck in the United States and Canada) 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.

For more details, go to: http://www.jnj.com/news/all/Janssen-Submits-Application-Seeking-Approval-Of-SIMPONI-In-European-Union-For-Non-Radiographic-Axial-Spondyloarthriti