MSD (Merck & Co.) today announced that on 22 June the European Commission approved Simponi (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA). This follows CHMP positive opinion issued in May 2015, which was based on the findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with Simponi, compared with patients treated with placebo, over 16 weeks.

Nr-axial SpA and ankylosing spondylitis (AS) come under the umbrella term of Axial Spondyloarthritis (axial SpA), which is a painful and potentially progressive condition that mainly affects the spine and pelvic joints, commonly characterised by chronic lower back pain and stiffness. AS patients have evidence of radiographic damage, whereas nr-axial SpA patients do not.

"The burden of disease is similar in nr-axial SpA and AS, and effective suppression of inflammation results in a considerable improvement of pain, stiffness, function, and more general quality of life outcome parameters," explains GO-AHEAD study author Professor Joachim Sieper, Consultant and Head Rheumatologist at the Charité University Hospital, Berlin. "These results in this early phase of axial spondyloarthritis were at least as good as in the more established ankylosing spondylitis in previous trials."

For more details, go to: http://www.prnewswire.com/news-releases/simponi-receives-european-commission-approval-for-treatment-of-non-radiographic-axial-spondyloarthritis-510017691.html