Crohn's Disease Drug Cleared for Children

WASHINGTON -- Federal regulators approved Remicade as a treatment for Crohn's disease in children on Friday, just days after publication of a study linking the Johnson & Johnson drug to an increased risk of some cancers in rheumatoid arthritis patients.

The Food and Drug Administration said that expanding availability of the injectable drug would provide a much-needed option for children who suffer from Crohn's, in which chronic inflammation of the walls of the intestines can cause diarrhea, cramping, abdominal pain and bleeding. In 1998, Remicade became the first approved treatment for Crohn's disease in adults.

"We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, in a statement.

Approval comes after Wednesday's publication in the Journal of the American Medical Association of a study in which researchers said they found an apparent link between Remicade and a second drug, Humira, and some types of cancer in rheumatoid arthritis patients. Those cancers include skin, gastrointestinal, breast and lung tumors.

The FDA-approved labeling for Remicade, also called infliximab, already mentions the drug's association with an increased risk of lymphoma and other cancers, including skin, breast and colorectal, the regulatory agency and the drug's manufacturer both said. The label also mentions an increased risk of serious and sometimes fatal infections, as well as disorders of the blood and central nervous system.

Centocor, a J&J subsidiary, and Abbott Laboratories, which makes Humira, previously said the JAMA study does not prove their drugs are at fault and added that the research was flawed.

"The issue is that it's not really new news," Centocor spokesman Michael Parks said Friday. "This information is covered in our label."

The FDA also said it received reports of an aggressive and frequently fatal form of lymphoma in adolescent and young adult Crohn's patients treated with drugs that suppress the immune system. In some of those cases, the patients also received Remicade, according to Centocor. The agency and Centocor said they were revising Remicade's label to reflect those findings as well. Centocor emphasized that none of the lymphoma patients received Remicade alone.

Both Crohn's and rheumatoid arthritis are autoimmune diseases, in which the immune system attacks the body's soft tissues, including those that line the intestines and joints.

Remicade, a genetically engineered monoclonal antibody, works by binding to a protein that contributes to the chronic inflammation that is a hallmark of autoimmune diseases, according to the FDA.

___

On the Net:

Food and Drug Administration Q&A about Remicade: http://www.fda.gov/cder/drug/infopage/infliximab/qa.htm