Conventional therapies in this indication include corticosteroids, immunomodulators and primary nutrition therapy. The approval follows a positive opinion granted in March by the Committee for Medicinal Products for Human Use.
Remicade is the first and only biologic therapy approved in the EU for the treatment of pediatric CD, the companies said. The drug is already approved in pediatric CD patients in the US, and is approved for CD in adults in both the EU and the US.
The approval was based on data from a phase III trial of 112 patients between the ages of six and 17 with moderate to severe, active Crohn’s disease who had failed other therapies. At week 54, the proportion of subjects in clinical remission was 55.8%. In addition, statistically and clinically significant improvements in quality of life and height, as well as a significant reduction in corticosteroid use, were observed.
Centocor discovered Remicade and has exclusive marketing rights to the product in the US. Schering-Plough markets Remicade in all countries outside of the US, except in Japan and parts of the Far East where Tanabe Seiyaku markets the product and in China where Xian-Janssen markets Remicade.