Centocor, Inc. and Schering-Plough Corporation announced 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 European Union (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, a company release said.
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 multi-centre, 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," Paul Rutgeerts, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium and lead investigator of the ACT 2 clinical trial said adding, "These patients with UC had limited treatment options, with many facing surgery. Remicade represents a significant advance for these patients."
This approval follows a positive opinion adopted on January 26, 2006 by the EU's Committee for Medicinal Products for Human Use (CHMP), for the European Agency for the Evaluation of Medicines Agency (EMEA). The Commission approval will now allow Marketing Authorization with unified labelling in all EU-member states, including the current 25 member states as well as Iceland and Norway.
Robert J. Spiegel, chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute said, "This latest authorization further validates the utility of Remicade as a treatment in a number of inflammatory diseases. Remicade is now approved in the European Union in the treatment of ulcerative colitis, Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. "