Remicade Set for Priority Review

The FDA gives the J&J drug priority status in its review as a treatment of Crohn's disease in children.
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Remicade drug received priority-review status for treating Crohn's disease in children.

The decision was based on phase III trial data showing the drug was effective in children with moderate to severe Crohn's disease, Johnson & Johnson's Centocor unit said Tuesday. Crohn's causes inflammation of the small intestines, which leads to diarrhea, fever, abdominal pain and weight loss. In children, the condition may cause developmental delays and stunted growth.

The Food and Drug Administration grants priority review status to drugs that are considered to be significant advances from current treatments available for a disease. In late 2003, Remicade received orphan drug designation for pediatric Crohn's disease. It received fast-track review status in August 2004, which allows drug data to be submitted to the agency on a rolling basis instead of all at once.

Remicade is currently approved to treat Crohn's disease in adults, along with various other conditions, such as rheumatoid arthritis and ulcerative colitis.

In the clinical trial, after 10 weeks of treatment, 88.4% of children with moderately to severely active Crohn's disease who didn't adequately respond to conventional treatment responded to Remicade. After one year, 63.5% of patients who took Remicade every eight weeks showed a response to the drug. The disease was in remission in more than half of the patients on the drug after one year.

"Remicade, if approved for the treatment of pediatric Crohn's disease, would represent a major advancement for children with this serious condition. We look forward to working closely with the FDA as it reviews these data for approval," said Jerome Boscia, senior vice president of clinical research and development at Centocor, in a press release.

Crohn's disease affects 400,000 to 600,000 people in North America, according to the Mayo Clinic.