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MSD, known as Merck & Co., Inc. in the United States and Canada, announced that SIMPONI® (golimumab) has received CHMP positive opinion for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA) 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). (1) Once the EU commission issues their EC decision, and if approved, nr-axial SpA patients can be considered for the once-monthly subcutaneous injection with SIMPONI® (golimumab).
The CHMP positive opinion was based on the findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with golimumab, compared with patients treated with placebo, over 16 weeks. (2)
“The indication of SIMPONI® in non-radiographic axial spondyloarthritis will add to a number of existing indications in rheumatology and gastroenterology”, explains Dr Sean Curtis, VP, Immunology Clinical Research at MSD, “physicians will have an option to help address the treatment needs of a significant group of their patients.”
The term axial spondyloarthritis (axial SpA), which encompasses both nr-axial SpA and ankylosing spondylitis (AS), (3) is a painful and potentially progressive condition that mainly affects the spine and pelvic joints, commonly characterised by chronic lower back pain and stiffness. (4) The burden of disease in nr-axial SpA is similar to AS. (5)
Once approved, SIMPONI® will become available as a treatment option for patients with severe active nr-axial SpA. This will add to the existing approved indications in rheumatology: AS, psoriatic arthritis (PsA) and rheumatoid arthritis (RA). SIMPONI® is also approved for the treatment of ulcerative colitis. (6)