FDA OK's Remicade in Children
Posted on: Friday, 19 May 2006, 12:09 CDT
The U.S. Food and Drug Administration said Friday it has approved Centocor's Remicade for use in children with Crohn's disease.
The drug is a genetically engineered monoclonal antibody that reduces the bowel inflammation that marks the condition by blocking the action of tumor necrosis factor-alpha, the agency said.
Remicade was approved in 1998 to treat Crohn's disease in adults.
The FDA said the approval marks the first time children with Crohn's disease who have moderate to severe disease despite use of traditional or conventional therapies have an effective treatment.
Remicade is not a cure, but it provides a much-needed option for reducing the symptoms and inducing and maintaining disease remission in children who have no other safe and effective therapy, FDA official Steven Galson said in a statement. We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated, he said.
Remicade was tested in 112 children age 6 to 17 who had moderately to severely active Crohn's disease and failed conventional therapies.
Crohn's disease can cause a range of symptoms including diarrhea, cramping, abdominal pain, gastrointestinal bleeding, and in some cases abnormal connections -- called fistulas -- leading from the intestine to the skin, FDA said.
Source: United Press International
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