CHMP recommends approval of Simponi (golimumab) for non-radiographic axial spondyloarthritis-Janssen

The CHMP of the European Medicines Agency adopted a positive opinion recommending approval for the use of subcutaneous Simponi (golimumab), from Janssen, for the treatment of adults with severe active non-radiographic axial spondyloarthritis (nr-AxSpA) with objective signs of inflammation 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). Based on the CHMP's positive opinion, a final decision from the European Commission is expected during the third quarter of 2015.

The CHMP adopted the opinion based on a review of data from the Phase III GO-AHEAD trial, which evaluated the efficacy and safety of Simponi compared with placebo in adults with severe active nr-AxSpA.