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Centocor seeks new use for Remicade

Centocor Ortho Biotech has filed a supplemental application with the US Food and Drug Administration to expand the approved indications of Remicade

Johnson and Johnson's Centocor Ortho Biotech has filed a supplemental biologics licence application with the US Food and Drug Administration (FDA) seeking to expand the approved indications of Remicade (infliximab) to include the treatment of moderately to severely active ulcerative colitis (UC) in paediatric patients who have had an inadequate response to conventional therapy.

The drug, which is already approved for the same indication in adults, has US orphan status for the paediatric use. Remicade is also approved in the US to treat Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis in adults, as well as for paediatric use in Crohn's disease.

Centocor's latest marketing submission for Remicade includes data from an open-label phase III trial that enrolled patients aged six through 17 with moderately to severely active UC who had failed conventional treatment.

The trial demonstrated Remicade's efficacy in inducing clinical response, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in paediatric patients, according to Centocor.

Ulcerative colitis is a chronic inflammatory bowel disease that can lead to bloody stools, severe diarrhoea and abdominal pain, which in turn can cause loss of appetite, weight loss, and fatigue.

Remicade is a TNF-blocker that must be administered as a two-hour infusion in a clinic or doctor's office every four to eight weeks.

4th January 2011

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