Centocor, Inc. announced today that REMICADE(R) (infliximab) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ulcerative colitis (UC), making REMICADE the first and only biologic approved for UC, a chronic inflammatory bowel disease (IBD).
REMICADE is now indicated for reducing signs and symptoms, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy. This is an unprecedented milestone in the treatment of moderate-to-severe UC; to date, no therapy has ever been indicated for mucosal healing and eliminating the use of corticosteroids.
“The approval of REMICADE for the treatment of UC represents a major breakthrough for patients suffering from this often debilitating disease,” said William J. Sandborn, M.D., professor of medicine, Mayo Clinic College of Medicine and head of the IBD Interest Group and director of the IBD Clinical Research Unit at Mayo Medical Center. “Not only did many patients in clinical trials experience a significant reduction in the occurrence of symptom flare- ups with REMICADE, some achieved clinical remission and mucosal healing as well. This is welcome news for these patients whose only option otherwise may have been surgery to remove their colons.”
REMICADE’s efficacy in the treatment of IBD is well established. First approved in the United States for the treatment of Crohn’s disease (CD) in 1998, REMICADE remains the only anti-tumor necrosis factor (TNF-alpha) therapy indicated for the treatment of CD. With this new approval for the treatment of ulcerative colitis, REMICADE is now the only biologic indicated for the treatment of both types of inflammatory bowel diseases, CD and UC.
In addition to UC and CD, REMICADE is also indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. More than 600,000 patients have been treated with REMICADE worldwide. This new approval for the treatment of UC continues to demonstrate the benefit of REMICADE across immune-mediated inflammatory diseases.
