Janssen Biotech announced that the FDA has approved Simponi (golimumab) injection for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. Also, Simponi has been approved to induce clinical remission and achieve and sustain clinical remission in induction responders.
Simponi is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.
The approval is supported by data from PURSUIT clinical trials that evaluated patients with moderately to severely active UC who had previously failed or were intolerant to conventional treatments. Data showed significantly greater proportions of patients in the Simponi group achieved clinical response, remission, and improvement at Week 6. Similarly, greater proportions of patients in the Simponi group maintained clinical response compared with the placebo group through Week 54.
Simponi is already indicated for moderately to severely active rheumatoid arthritis, in combination with methotrexate; for active psoriatic arthritis, alone or with methotrexate; and for active ankylosing spondylitis.
For more information call (800) 526-7736 or visit Simponi.com.