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FDA grants priority review of Centocor's Remicade for pediatric Crohn's disease
By Lisa Kerner
Erie, Pa., April 4 - Centocor, Inc. said its supplemental Biologics License Application for Remicade (infliximab) for the treatment of pediatric Crohn's disease has been accepted and designated for priority review by the Food and Drug Administration.
Priority review is granted by the FDA to products that are considered to be a potential therapeutic advance over current therapies, according to a company news release.
Centocor said it is seeking approval for Remicade for the treatment of moderately to severely active pediatric Crohn's disease in patients who have had an inadequate response to conventional therapies for the chronic condition.
The filing is based on results of Centocor's phase 3 study known as Reach (a Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF Monoclonal Antibody Remicade in Pediatric Subjects with Moderate to Severe Crohn's Disease).
In the trial, 88.4% of pediatric patients achieved clinical response at week 10 when treated with Remicade. More than half of the patients treated with Remicade every eight weeks were in clinical remission at the end of one year, the company said.
Crohn's disease symptoms include diarrhea, fever, abdominal pain and weight loss, as well as delayed development and stunted growth in children with the condition.
Remicade is FDA-approved for treatment of adults with moderate to severe Crohn's disease and for the treatment of moderate to severe ulcerative colitis. The drug received orphan drug status for the treatment of pediatric Crohn's disease.
Centocor, a wholly owned subsidiary of Johnson & Johnson, delivers biomedicines for the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and ulcerative colitis. The company is located in Horsham, Pa.
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