|
Source – The Food and Drug Administration (FDA) – The FDA has approved Remicade (infliximab) to treat children with active Crohn’s disease, a chronic, inflammatory condition of the bowel that can be severely debilitating. Remicade is a genetically engineered monoclonal antibody, which reduces inflammation (swelling/redness) by blocking the action of tumour necrosis factor-alpha (TNF-α).
The safety and effectiveness of Remicade in paediatric Crohn’s disease were assessed in a randomised study in 112 children who were 6
to 17 years old with moderately to severely active Crohn’s disease who had an inadequate response to convention therapies. The proportion of these patients who achieved clinical response compared
favourably with the proportion of these patients who achieved clinical response compared favourably with the proportion of adults in an earlier Remicade study in adult Crohn’s disease, and the
paediatric trial’s results showed no new safety concerns not already expressed in the product’s current label.
In general, the safety profile for Remicade in the paediatric trial was similar to the data that was presented at FDA Arthritis Advisory
Committee meeting in March 2003, and that dealt with the extent to which anti-TNF therapies may increase the risk of serious infections and malignancies, such as sepsis and pneumonia in certain people.
The risks are included in the current labels for all approved TNF-alpha blocking agents, including Remicade.
Remicade (infliximab) is not licensed for use in children in children in the United Kingdom
For more information go to: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01376.html
Prepared by Susan Wileman Medicines Information Technician
Date of Preparation: 22nd May 2006
|
