The European Commission has approved MSD’s biologic Simponi for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis. 

The decision comes on the back of a positive opinion by the Committee for Medicinal Products for Human Use in May after data from the GO-AHEAD study showed “significant clinical improvement” in patients taking the drug compared to those on placebo.

With the approval, Simponi (golimumab) can now be considered a treatment option for adult patients with severe, active nr-axial SpA with objective signs of inflammation who are unresponsive or intolerant to nonsteroidal anti-inflammatory drugs.

The drug has already received a green light in Europe for treating ankylosing spondylitis which, together with nr-axial SpA, comes under the umbrella term of axial spondyloarthritis, a painful and potentially progressive condition that mainly affects the spine and pelvic joints, commonly characterised by chronic lower back pain and stiffness.

For more details, go to: http://www.pharmatimes.com/Article/15-07-06/Europe_clears_Simponi_for_non-radiographic_axial_spondyloarthritis.aspx