EU approves Simponi (golimumab) for non-radiographic axial spondyloarthritis-MSD

MSD announced that 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.

European Commission approval in the nr-axial SpA indication means that Simponi is now - in addition to the already existing approval for ankylosing spondylitis - a treatment option for adult patients with severe, active nr-axial SpA with objective signs of inflammation (OSI), as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).