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news.Centocor, a unit of Johnson & Johnson, has said that the FDA has approved Remicade for patients with moderate to severe ulcerative colitis, who have had an inadequate response to conventional therapy.
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The approval is based on one-year data from a trial, which found that patients receiving Remicade were nearly three times as likely as patients in the placebo group to maintain clinical remission from their symptoms after one year. In addition, 45% of Remicade patients had mucosal healing at week 54 compared to 18% of patients in the placebo group.
Remicade is already approved for the treatment of inflammatory bowel disease (IBD), and Crohn’s disease.
With this new expanded indication for maintenance therapy in UC, Remicade is now the only biologic indicated for inducing and maintaining clinical remission of both types of IBD.
“With this new indication, patients for whom effective maintenance therapy is critical now have an additional therapeutic option that may reduce the need for surgical intervention,” said Richard Geswell, president of the Crohn’s & Colitis Foundation of America.