- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval for Janssen's (NYSE:JNJ) Simponi (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA) who have had an inadequate response to or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
- Nr-axial SpA is a painful and potentially progressive condition that principally affects the spine and pelvic joints. It is characterized by chronic lower back pain and stiffness.
- Simponi, currently cleared for the treatment of moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis and moderate-to-severe ulcerative colitis, is a human monoclonal antibody that binds to tumor necrosis factor (TNF)-alpha, a protein that is overproduced in chronic inflammatory diseases. Merck (NYSE:MRK) has the marketing rights in the EU.