Ulcerative Colitis

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 (Active ACT 1 and ACT 2 were multicenter, Phase 3, 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.

"Our research demonstrated that UC patients treated with REMICADE achieved mucosal healing and disease remission while they had failed conventional therapies," said Paul Rutgeerts, MD, PhD, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium and lead investigator of the ACT 2 clinical trial.

"These patients with UC had limited treatment options, with many facing surgery.

REMICADE represents a significant advance for these patients." This approval follows a posi...

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