REMICADE (infliximab) - Maladies inflammatoires chroniques de l'intestin chez l'enfant

The actual clinical benefit of REMICADE (infliximab) remains significant for the treatment of:

• severe active Crohn’s disease, in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. REMICADE has been studied only in combination with conventional immunosuppressive therapy.
• severe active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.

The Committee deems that the data from this study are not likely to modify the assessment of the clinical added value expressed in the previous opinions of 4 March 2009 and 6 March 2013.