FDA approves Centocor's Remicade for children with Crohn's disease

By Lisa Kerner

Erie, Pa., May 19 - The Food and Drug Administration approved Centocor Inc.'s Remicade (infliximab) to treat children with active Crohn's disease, a chronic, often debilitating, inflammatory condition of the bowel.

Remicade, a genetically engineered monoclonal antibody, reduces inflammation by blocking the action of tumor necrosis factor-alpha (TNF-a), according to a news release.

"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," said Steven Galson, director of the FDA's Center for Drug Evaluation and Research, in a news release.

"We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated."

Centocor said the approval was based on data from its phase 3 randomized, multicenter, open-label study (Reach) of Remicade's safety and effectiveness in 112 children ages six years old to 17 years old with moderately to severely active Crohn's disease.

In the trial, nearly 90% of patients achieved clinical response at week 10 when treated with Remicade.

During the eight-week maintenance follow-up, about 64% of the patients were in clinical response at one year and 56% were in clinical remission at the end of one year, the company said.

Centocor said it has added to the boxed warning in the labeling for Remicade a description of rare post-marketing cases of hepatosplenic T-cell lymphoma that have been reported in adolescents and young adults with Crohn's disease.

According to the release, about 100,000 children under the age of 17 suffer from inflammatory bowel diseases, which include Crohn's disease and ulcerative colitis.

A wholly owned subsidiary of Johnson & Johnson, Centocor is a biomedical company based in Horsham, Pa.

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