The US Food and Drug Administration has cleared the use of Johnson & Johnson unit Centocor’s anti-TNF therapy Remicade (infliximab) in children with active Crohn's disease, making it the first and only biologic to be approved for this debilitating illness.
“Remicade is not a cure, but it provides a much-needed option for reducing the symptoms and inducing and maintaining disease remission in children who have no other safe and effective therapy,” according to Dr Steven Galson, Director of the FDA's Center for Drug Evaluation and Research. "We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated," he added.
The drug’s safety and efficacy in a paediatric setting were evaluated in a randomised study involving 112 children aged six to 17 years with moderately-to-severely active Crohn's disease. As well as establishing the drug’s efficacy in children, the trial revealed no new safety concerns above those already addressed in its label.
Remicade was first approved in 1998 for the treatment of adults with Crohn's disease, and its label describes the extent to which anti-TNF therapies may increase the risk of serious infections and malignancies, such as sepsis and pneumonia in certain patients, the FDA noted.
Recently, the agency expanded the warnings section of Remicade’s label to include the potential increased risk of developing lymphoma, after it received six reports of hepatosplenic T-cell lymphoma in patients taking the drug for varying lengths of time.
In a statement, the FDA said it will continue to: “Actively and carefully monitor the safety experience with Remicade and similar therapies in an effort to maximise their very real benefits yet limit, to the degree possible, the potential for very serious toxicities.”
Remicade is already a billion-dollar selling drug and seems to have wide-reaching potential in the inflammatory field. Earlier this year, Johnson & Johnson's partner Schering-Plough scored a win when the drug became the first biologic to be cleared for the use of ulcerative colitis in Europe, and a recent trial also confirmed the agent’s effectiveness in treating psoriasis.