Simponi gains EU Commission approval to treat axial spondyloarthritis

Merck announced that on June 22, the European Commission approved Simponi to treat non-radiographic axial spondyloarthritis, according to a press release.

The decision comes after the Committee for Medicinal Products for Human Use issued a positive opinion in May on the use of Simponi (golimumab, Janssen), a tumor necrosis factor-alpha inhibitor, for treatment of axial spondyloarthritis (SpA) following the GO-AHEAD trial and earlier approval of its use in the treatment of ankylosing spondylitis (AS). It is indicated for use in adults with severe, active non-radiographic SpA who display inflammation that can be objectively demonstrated by MRI or elevated C-reactive protein, according to the release.

“Effective suppression of inflammation results in a considerable improvement of pain, stiffness, function and more general quality-of-life outcome parameters,” Joachim Sieper, MD, study author, consultant and head rheumatologist at the Charité University Hospital, Berlin, said in the press release. “These results in this early phase of axial spondyloarthritis were at least as good as in the more established ankylosing spondylitis in previous trials.”

Until now, golimumab was only approved for rheumatoid arthritis, AS, psoriatic arthritis and ulcerative colitis in Europe, and it is licensed by Janssen to a subsidiary of Merck for marketing across Europe and Turkey. Golimumab is currently approved in the U.S. for axial spondyloarthritis, as well as rheumatoid arthritis and psoriatic arthritis in combination with methotrexate and for ulcerative colitis.

Reference: www.ema.europa.eu.