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.
Approval in the nr-axial SpA indication comes ahead of September 2015 draft guidance from the National Institute for Health and Care Excellence on the use of biologics for the treatment of axial spondyloarthritis, MSD noted.
Simponi has also already bagged clearance in Europe for psoriatic arthritis and rheumatoid arthritis, as well as ulcerative colitis.