MSD's Simponi treatment for patients with non-radiographic axial spondyloarthritis received the CE Mark from the European Commission.
Here are five things to know:
1. The clearance, issued in May, was based on findings from the GO-AHEAD study demonstrating significant clinical improvement in patients with active nr-axial SpA who underwent Simponi. The control patients underwent a placebo treatment over 16 weeks.
2. The nr-axial SpA and ankylosing spondylolisthesis will be under MSD's Axial Spondyloarthritis product family. The products treat patients with progressive conditions impacting the spine and pelvic joints.
3. Healthcare providers can identify appropriate patients for the treatment with objective signs of inflammation indicated by elevated C-reaction protein and/or MRI evidence. The patients undergoing treatment after nonsteroidal anti-inflammatory drugs failed.
4. Simponi is already indicated for patients with ankylosing spondylitis in rheumatology as well as patients with psoriatic arthritis and rheumatoid arthritis. Simponi is also approved to treat ulcerative colitis.
5. Early results show Simponi for axial spondyloarthritis are as good as more established ankylosing spondylitis in previous trials.