FDA Approves Remicade for Children with Ulcerative Colitis

The US Food and Drug Administration (FDA) has granted another approval for Johnson & Johnson’s drug Remicade, this time for the treatment of ulcerative colitis in paediatric patients who have had an inadequate response to conventional therapy.

This marks the 16th approval of Remicade (infliximab) in the USA and the seventh for the anti-tumor necrosis factor (TNF)-alpha drug in the treatment of inflammatory bowel disease, including adult and paediatric Crohn’s disease.

The latest approval is backed by a Phase III trial which showed that treatment with Remicade 5 mg/kg induced clinical response in 73% of patients at week 8.  The drug demonstrated a safety profile consistent with previous clinical trials conducted in adults.

Johnson & Johnson quoted Jeffrey Hyams, professor of paediatrics at University of Connecticut School of Medicine and the lead study investigator, as saying that Ulcerative Colitis can be a devastating disease and “previously there had been no approved therapeutic options for paediatric patients who had an inadequate response to conventional therapy”.  Hyams added that the approval of infliximab, which was approved for this indication in Canada earlier this month, “represents an important treatment milestone in the care of children stricken with this inflammatory bowel disease”.

The latest approval will boost revenues banked by Johnson & Johnson for Remicade, the second-quarter sales of which were up 21.3% to $1.37 billion.



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