CHMP recommends Remicade (Janssen Biologic) for Paediatric Ulcerative Colitis

The CHMP has issued a positive opinion for Remicade (infliximab) from Janssen Biologic for the treatment of severely active Ulcerative Colitis in paediatric patients aged between six to 17 who have had an inadequate response to conventional therapy, or who or intolerant to, or have medical contraindications to these therapies. The recommendation is based on a Phase III randomised, open-label trial in 60 children showing that the drug produced a clinical response in 73% of subjects by week eight, and maintained remission in up to 38% of responders by week 54. Remicade is approved for this indication in the USA and Canada.