The US Food and Drug Administration has approved the use of Johnson & Johnson unit Centocor’s rheumatoid arthritis drug, Remicade (infliximab), for the treatment of ulcerative colitis, marking the first biologic to be cleared for the condition, a chronic inflammatory bowel disease.

The agent is now indicated for reducing the signs and symptoms of UC, achieving clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately-to-severely active disease who have had an inadequate response to conventional therapy. This represents an unprecedented milestone in the treatment of the condition as, to date, no therapy has ever been cleared for both mucosal healing and eliminating the use of steroids, Centocor noted.

Said William Sandborn, MD, professor of medicine at the Mayo Clinic College of Medicine and head of the Center’s IBD Interest Group and director of the IBD Clinical Research Unit: “Not only did many patients in clinical trials experience a significant reduction in the occurrence of symptom flare- ups with Remicade, some achieved clinical remission and mucosal healing as well. This is welcome news for these patients whose only option otherwise may have been surgery to remove their colons.”

In addition to ulcerative colitis and Crohn’s disease - the drug’s first approved indication in 1998 - Remicade is also indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. Its new use for ulcerative colitis will no doubt boost its already-impressive sales, which hit $2.15 billion in 2004.