UPDATE 2-US OKs J&J drug for children with Crohn's disease

 

U.S. regulators approved wider use of Johnson & Johnson's (JNJ.N: Quote, Profile, Research) drug Remicade on Friday but also said a new warning was being added about reports of an often-fatal lymphoma in a small number of users.

The company won permission to market the prescription drug for treating children with active Crohn's disease, a chronic bowel inflammation that can be debilitating.

 

"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. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.

 

The FDA cleared Remicade for children who have moderate to severe Crohn's disease symptoms despite treatment with older therapies. Safety and effectiveness was not studied in children younger than 6, the FDA noted.

Remicade already is sold for treating rheumatoid arthritis and other conditions.

 

The FDA said it had received reports of rare cases of an aggressive and often-fatal lymphoma in adolescents and young adults treated with Remicade. The agency is working with the manufacturer to add the information to the drug's prescribing instructions, an FDA statement said.

 

The company is aware of six reports of hepatosplenic T-cell lymphoma in Crohn's disease patients who took Remicade for varying lengths of time, said Michael Parks, a spokesman for Johnson & Johnson unit Centocor.

It is unclear if Remicade contributed to the lymphoma, he added. The patients also were treated with other drugs to suppress the immune system.

 

"We can't tell what contribution, if any, Remicade has made. That said, we believe that notifying physicians and making them aware of reported cases is important. We will continue to look into these cases with the FDA," Parks said.

Remicade, known generically as infliximab, is part of a group of drugs that suppress tumor necrosis factor-alpha, a protein that plays a key role in inflammation. Other drugs in the class include Amgen Inc.'s (AMGN.O: Quote, Profile, Research) Enbrel and Abbott Laboratories Inc.'s (ABT.N: Quote, Profile, Research) Humira. All of them carry warnings about the possibility of malignancies or serious infections.