MSD announces EC approval of SIMPONI (golimumab) for treatment of adult patients with nr-axial SpA

Jun 26 2015

Adults with Non-radiographic Axial Spondyloarthritis can be considered for once-monthly subcutaneous injection with SIMPONI^® (golimumab)

MSD (Merck & Co., Inc., Kenilworth, New Jersey, USA) 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."

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).

"The indication of SIMPONI^® in non-radiographic axial spondyloarthritis adds to a number of existing indications in rheumatology and gastroenterology," explains Dr Sean Curtis, VP, Immunology Clinical Research at MSD. "Physicians now have an option to help address the treatment needs of a significant group of their patients."

In rheumatology, SIMPONI^® is already indicated for AS, psoriatic arthritis and rheumatoid arthritis. SIMPONI^® is also approved for the treatment of ulcerative colitis.

SOURCE MSD