REMICADE APPROVED IN EU TO TREAT ULCERATIVE COLITIS

Centocor and Schering-Plough have announced that the European Commission has granted approval of Remicade (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in patients 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 approval makes Remicade the first biologic therapy approved to treat moderately to severely active UC in the EU, addressing an unmet medical need for patients who previously had limited treatment options. This new approval 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 clinical trials. ACT 1 and ACT 2 were multicenter, Phase III, randomized, double-blind, placebo-controlled, clinical 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.