FDA OKs Centocor's Remicade in pediatric CD

US drugmaker Centocor says that the US Food and Drug Administration has approved Remicade (infliximab) for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.

According to the Pennsylvania-headquartered firm, this approval establishes the agent as the first and only biologic therapy approved for the treatment of pediatric Crohn's, 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.

Earlier this year, the supplemental Biologics License Application for Remicade for the treatment of pediatric Crohn's was given priority review by the FDA. The drug, which is the global market leader among anti-tumor necrosis factor alpha therapies, is also approved for use against rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and ankylosing spondylitis, the firm noted.