Janssen Files New Application For Simponi For Nr-AxSpA In EU

Johnson & Johnson company Janssen Biologics announced that it has filed a Type II Variation application with the European Medicines Agency (EMA) for the approval of Simponi (golimumab) as treatment for severe, active, non-radiographic axial spondyloarthritis (nr-AxSpA).

Simponi is a human monoclonal antibody (mAb) designed to target and neutralize excess tumor necrosis factor (TNF)-alpha. TNF-alpha is a protein that causes inflammation and damage to bones, tissue, and cartilage when excessively produced in the body due to chronic inflammatory disease. The European Commission approved Simponi as treatment for several indications, including rheumatoid arthritis, ulcerative colitis, and severe, active ankylosing spondylitis. Janssen is in partnership with Merck for the marketing of Simponi, amending their agreement in July 2011 for the distribution rights to the drug.

The company’s recent filing is based on encouraging data from the Phase 3 trial conducted in collaboration with Merck. The placebo controlled, double blind, randomized GO-AHEAD trial investigated the safety and efficacy of Simponi in adults with active nr-AxSpA. The company said it will present the results of the trial at the upcoming American College of Rheumatology Annual Meeting 2014.

Newman Yeilding, VP, and Head of Immunology Development at Janssen R&D, said, “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. We look forward to collaborating with the European Medicines Agency to progress Simponi as a treatment for people living with non-radiographic axial spondyloarthritis.”

Non-radiographic axial spondyloarthritis is a type of chronic inflammatory disease of the spine characterized mainly by back pain and stiffness. While damage to joints might not be apparent initially, patients with nr-AxSpA will eventually progress to spinal deformity and dysfunction. Approximately 0.3 to 2.5 percent of the European population is afflicted with certain spondyloarthritis types.