EU OK's Schering's Remicade for colitis

KENILWORTH, N.J., March 9 (UPI) -- Schering-Plough said Thursday the European Commission approved Remicade for the treatment of ulcerative colitis.

The indication, which is for moderately to severely active ulcerative colitis in patients who have failed on conventional therapies, was supported by the ACT 1 and ACT 2 phase 3 trials.

"Our research demonstrated that UC patients treated with Remicade achieved mucosal healing and disease remission while they had failed conventional therapies," Paul Rutgeerts of the University Hospital Gasthuisberg in Leuven, Belgium, and lead investigator of the ACT 2 trial, said in a statement issued by Schering.

"These patients with UC had limited treatment options, with many facing surgery," Rutgeerts said. "Remicade represents a significant advance for these patients."

Remicade is approved in the European Union for several other inflammatory diseases, including Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.