CENTOCOR'S REMICADE WINS EXPANDED ULCERATIVE COLITIS INDICATION

Centocor announced that the FDA has approved Remicade (infliximab) for maintaining clinical remission and mucosal healing in patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. The approval is based primarily on one-year data from the ACT 1 randomized, double-blind, multicenter, placebo-controlled clinical trial, which found that patients receiving Remicade were more than twice as likely to be in clinical remission at week 54 compared with placebo (35 percent versus 17 percent). Furthermore, patients receiving Remicade were nearly three times as likely as patients in the placebo group to maintain clinical remission from their symptoms after one year. In addition, 45 percent of Remicade patients had mucosal healing at week 54 compared with 18 percent of patients in the placebo group.

The efficacy of Remicade in the treatment of inflammatory bowel disease (IBD) is well-established, according to Centocor. The drug was first approved in the United States for the treatment of Crohn's disease in 1998 and later approved for the treatment of UC in September 2005. With this new expanded indication for maintenance therapy in UC, Remicade is now the only biologic indicated for inducing and maintaining clinical remission of both types of IBD.

Remicade is the global market leader among anti-tumor necrosis factor alpha therapies and has demonstrated broad clinical utility in Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, UC and pediatric Crohn's disease.