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FDA approves J&J's Remicade for children

Johnson & Johnson's Remicade (infliximab) has received approval from the US Food and Drug Administration (FDA) for the treatment of ulcerative colitis in children over six years of age

Johnson & Johnson's (J&J) Remicade (infliximab) has received approval from the US Food and Drug Administration (FDA) for the treatment of ulcerative colitis in children over six years of age who have not responded to conventional therapy.

The approval is supported by data from a phase III trial that showed treatment with Remicade induced clinical response in 73 per cent of patients at week eight and demonstrated similar results concerning safety as found in previous studies in an adult population.

The FDA said: "Remicade reduces signs and symptoms of UC and induces and maintains clinical remission in these patients."

Remicade is already approved by the FDA for over 16 indications, including the treatment of rheumatoid arthritis and Chrohn's disease. This is its seventh approval in the field of inflammatory bowel disease (IBD).

The drug carries a boxed warning for risk of serious infections and cancer, and Dr Donna Griebal, director of the Division of Gastroenterology and Inborn Errors Products in the FDA's Center for Drug Evaluation and Research, said there are "serious risks" associated with the drug's use.

The drug is still only authorised for use in adults with ulcerative colitis in Europe.

26th September 2011

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