Remicade approved by EU

The European Commission has granted a European Union (EU) approval of Schering Plough's Remicade (infliximab) for maintenance dosing for sustaining clinical response and remission in patients with severe, active Crohn's disease (CD) who have responded to infliximab therapy.

'With the approval of Remicade for use as regular maintenance therapy for the treatment of Crohn's disease, patients will benefit from a therapy that has demonstrated the ability to both induce and sustain control of the painful and debilitating symptoms associated with this disease,' said Paul J. Rutgeerts, professor of medicine, University Hospital, Leuven, Belgium. 'This therapy also decreases the rate of complications,' he added.

The EU also approved Remicade for the treatment of ankylosing spondylitis (AS), a serious inflammatory disease that leads to stiffening and subsequent fusion of the spine. Remicade is the only biologic indicated for the treatment of Crohn's disease, rheumatoid arthritis (RA) and AS, and is the worldwide market leader among TNF-alpha therapies, with more than 400,000 patients treated.

The EU approval for Remicade maintenance dosing in Crohn's disease, a serious gastrointestinal disorder, is based on 54-week data from the ACCENT 1 trial, a large, multi-center trial that evaluated the safety and effectiveness of Remicade as a maintenance therapy for CD.

The study also evaluated the effect of a maintenance regimen on steroid use and health-related quality of life, and demonstrated the ability of Remicade to induce and maintain clinical remission of the disease when administered as a three-dose induction regimen followed by maintenance treatment every eight weeks.