Merck Sharp and Dohme receives nr-axial SpA approval for Simponi

Merck Sharp and Dohme has announced that its drug Simponi has been approved in Europe for the treatment of non-radiographic axial spondyloarthritis (nr-axial SpA).

The European Commission has approved the golimumab-based therapy for the treatment of adult patients with severe, active nr-axial SpA, following a recent positive recommendation from the Committee for Medicinal Products for Human Use.

Approval was based on findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with Simponi compared with placebo over a 16-week period.

It is intended for use among patients objective signs of inflammation, as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence, who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs.

Dr Raj Sengupta, consultant rheumatologist at the Royal National Hospital for Rheumatic Diseases in Bath, said: "Nr-axial SpA has an enormous impact on patients with significant pain and stiffness in their spines and peripheral joints. This can lead to impaired sleep, difficulty with work and maintaining relationships."

Simponi is also approved for the treatment of ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.