Remicade Gets UC Approval In EU

Centocor, Inc. and Schering-Plough Corp. have been granted approval from the European Commission for Remicade for the treatment of moderate to severe, active ulcerative colitis (UC) in patients who have had an inadequate response to conventional therapy or who are intolerant to such therapies. The approval makes Remicade the first biologic therapy approved to treat active UC in the EU and also marks the eighth indication Remicade has received in the EU for the treatment of immune-mediated inflammatory disorders.

The approval of Remicade for UC is based on data from the ACT 1 and ACT 2 (Active Ulcerative Colitis Trial) clinical trials. ACT 1 and ACT 2 were multicenter, Phase III, randomized, double-blind, placebo-controlled, trials conducted to evaluate the safety and efficacy of Remicade for the treatment of adult patients with moderately to severely active UC who experienced an inadequate response to conventional therapy.