FDA Approves Janssen’s Simponi To Treat Ulcerative Colitis in Adults

The Food and Drug Administration May 15 approved a new use for Simponi (golimumab) injection, to treat adults with moderate to severe ulcerative colitis.

Previously approved to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi now is approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy, the agency said. Simponi is marketed by Janssen Biotech Inc., which is based in Horsham, Pa.

Ulcerative colitis is a chronic disease that affects about 620,000 Americans, the agency said. ...