FDA approves Remicade for childhood Crohn’s disease

Remicade is a genetically engineered monoclonal antibody that reduces inflammation by blocking the action of tumor necrosis factor-alpha. The drugwas initially approved in 1998 to treat Crohn’s disease in adults.

According to Dr Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, there have so far been no satisfactory treatments for children with Crohn’s disease who have moderate to severe disease activity despite traditional or conventional therapies.

Crohn’s disease can cause diarrhea, cramping, abdominal pain, gastrointestinal bleeding, and in some cases creates abnormal connections (fistulas) leading from the intestine to the skin.

“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,” said Dr Galson. “We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated.”

The FDA also said that it has received rare post-marketing reports of an aggressive and often fatal type of T-cell lymphoma (hepatosplenic T-cell lymphoma) in adolescent and young adult patients with the Crohn’s disease.

In most, but not all cases, these patients were treated with standard immunosuppressive therapies in combination with Remicade. The FDA said that it is working with the manufacturer to address this risk by updating the warnings sections of the Remicade label.