Johnson & Johnson announced Friday that Remicade (infliximab) garnered FDA approval for use in children with moderate to severe active ulcerative colitis who have had an inadequate response to conventional therapy.
The decision, which follows a positive recommendation from an advisory panel in July, was based on data from a late-stage trial involving 60 children ages 6 years to 17 years with moderately to severely active ulcerative colitis, all of which had failed to respond to or tolerate conventional treatment. Johnson & Johnson noted that data showed that Remicade induced a clinical response in 73 percent of patients at week 8 and demonstrated a safety profile that was “consistent with previous clinical trials conducted in an adult population.”
The therapy is already approved as a treatment for adults with ulcerative colitis, as well as several other conditions.
