Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. SIMPONI is the first and only subcutaneously administered anti-tumor necrosis factor (TNF)-alpha therapy approved to induce and maintain clinical response and improve endoscopic appearance of the mucosa during induction. In addition, SIMPONI is indicated to induce clinical remission and achieve and sustain clinical remission in induction responders. As many as 700,000 people in the United States are affected by UC1, a chronic inflammatory bowel disease (IBD) marked by inflammation and ulceration of the innermost lining of the colon.
“The FDA approval of SIMPONI brings an important, new subcutaneous therapeutic option to adults living with moderate to severe ulcerative colitis, a disease where treatment options have been limited,” said William Sandborn, MD, professor and chief of the Division of Gastroenterology at the University of California, San Diego (UCSD) School of Medicine, director of the UCSD Inflammatory Bowel Disease Center, and lead study investigator. “SIMPONI has demonstrated significant benefits in the treatment of ulcerative colitis, a chronic inflammatory bowel disease, and represents a meaningful addition to the treatment armamentaria for gastroenterologists.” For the treatment of UC, the SIMPONI dose regimen consists of 200 mg subcutaneously injected at week 0, followed by 100 mg at week 2 and then 100 mg every 4 weeks, thereafter.