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news.The FDA has given its final approval for Centocor's drug, Remicade, for the treatment of ulcerative colitis, a chronic inflammatory bowel disease. The approval makes Remicade the first and only biologic approved for the treatment of the disease.
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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 ulcerative colitis who have had an inadequate response to conventional therapy.
According to the company, Remicade is the first therapy to be indicated for mucosal healing and eliminating the use of corticosteroids in ulcerative colitis.
“The approval of Remicade for the treatment of ulcerative colitis represents a major breakthrough for patients suffering from this often debilitating disease,” said Dr William Sandborn, professor of medicine, Mayo Clinic College of Medicine and head of the IBD Interest Group. “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.”
In addition to ulcerative colitis, Remicade is also indicated for the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.