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Co-developed by Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP), REMICADE® (infliximab) was first approved in the U.S. ( by the USFDA) in 1998 as treatment U.S. for adult Crohn's disease (CD) and later, in 2005, for adult ulcerative colitis.

REMICADE® is a monoclonal antibody that specifically targets TNF-alpha, which has been shown to play a role in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO).

REMICADE® is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent approved for the treatment of both RA and CD in North America, the EU and Japan.

The USFDA approval of REMICADE® in May 2006 for pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy has made REMICADE® the only biologic therapy for Crohn’s disease.

Now, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending the approval of REMICADE® for the treatment of severe, active Crohn's disease (CD) in pediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy, or who are intolerant to, or have contraindications for, such therapies.

...pediatric CD, a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain, weight loss and, in some sufferers, delayed development and stunted growth.

Once the European Commission approved of the recommendation, REMICADE® will be the first and only biologic therapy approved in the EU for the treatment of pediatric CD.

Find more details from the press release.