Schering-Plough receives EU paediatric Crohn’s drug approval

Schering-Plough and Centocor have announced the approval of a new indication for Remicade (infliximab) from the European Commission. Following this revised labelling, the compound can be used to treat severe, active Crohn’s disease in younger patients.

The compound is now indicated for patients aged six to 17 who are intolerant, have contraindications or have not sufficiently responded to traditional treatments, including primary nutrition therapy and the administration of an immunomodulator or corticosteroid.

Approval from the commission for this indication follows the receipt of a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency received in March 2007. Approval from the US Food and Drug Administration was granted in May 2006.

Salvatore Cucchiara, of the department of paediatrics, gastrointestinal motility and endoscopy unit at the University of Naples, commented that Crohn’s disease can cause a major adverse affect on the quality of life of younger patients with the condition.

“Infliximab provides physicians with a new treatment option that addresses the unique aspects of this difficult-to-treat disease in the paediatric population.”

In December 2005, the New England Journal of Medicine published the results of phase III clinical trials showing that administration with Remicade can improve the condition of ulcerative colitis in patients.