The Food and Drug Administration in the U.S. has given approval for the drug Remicade for use in children with active Crohn's disease(CD), a chronic and debilitating condition.
Crohn's disease is an inflammation of the gastrointestinal tract which causes diarrhea, fever, abdominal pain, weight loss and, in some sufferers, delayed development and stunted growth.
Although it can involve any area of the gastrointestinal tract from the mouth to the anus, it most commonly affects the small intestine and/or colon.
Remicade already has approval for treating rheumatoid arthritis and other conditions but the drug will carry an added warning of the small risk of an often-fatal lymphoma.
According to drug company Johnson & Johnson the drug is the first and only biologic therapy that has been approved for the treatment of pediatric Crohn's disease.
It apparently reduces the signs and symptoms of the disease and induces and maintains remission in children with moderate or severe Crohn's disease who have not responded to conventional therapy.
The approval was based on data from a trial of 112 patients aged 6 to 17 years which found that children with moderate to severe active Crohn's disease after 10 weeks of therapy with Remicade responded well and more than half were in remission at the end of one year.
Approximately 100,000 children under the age of 17 suffer from inflammatory bowel diseases (IBD), which include CD and ulcerative colitis (UC).
More than 700,000 patients have been treated with Remicade worldwide for UC in adults, IBD, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.