The Food and Drug Administration in the U.S. have given an approval for the drug Remicade for use in children with active Crohn's disease (CD), which is a chronic and debilitating condition.
Crohn's disease is an inflammation of the gastrointestinal tract that causes diarrhea, fever, abdominal pain, weight loss and, in some times, delayed development and stunted growth. Though it can involve any area of the gastrointestinal tract from the mouth to the anus, it commonly affects the small intestine.
Remicade has already been approved for treating rheumatoid arthritis and other conditions but now the drug will carry an additional warning about the small risk of an often-fatal lymphoma. It has been found that Remicade and other TNF blockers, may increase the risk of lymphoma or other cancers, and is not recommended for people with heart failure. There are also reports on the drug as it could cause serious infections, including tuberculosis (TB), sepsis and pneumonia, liver injury, and blood disorders.
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. The officials said that the drug helps in reducing the signs and symptoms of the disease and helps to maintain remission in children suffering from moderate or severe form of Crohn's disease, and those who have not responded to regular treatment.
The approval was passed after a data from a clinical trial of 112 patients aged 6 to 17 years, found that the 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). Remicade, known generically as infliximab, belongs to a class of drugs that suppress tumor necrosis factor-alpha, a protein involved in inflammation.