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.
Remicade, known generically as infliximab, belongs to a class of drugs that suppress tumor necrosis factor-alpha, a protein involved in inflammation.
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 have been reports of serious infections, including tuberculosis (TB), sepsis and pneumonia, liver injury, and blood disorders.
There have also been rare reports of a type of blood cancer in patients on Remicade or other TNF blockers which may increase the risk of lymphoma or other cancers.
But it thought that people who have been treated for rheumatoid arthritis, Crohn's disease, ankylosing spondylitis or psoriatic arthritis for a long period may possibly be more prone to develop lymphoma.
Other drugs in the same class also carry warnings about the possibility of malignancies or serious infections.