Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News Schering-Plough’s Remicade given approval recommendation for Crohn’s treatment

Schering-Plough’s Remicade given approval recommendation for Crohn’s treatment

26th March 2007

Schering-Plough this morning welcomed the approval of the European Union for the use of Remicade in treating severe cases of Crohn’s disease in paediatric patients.

The recommendation of the Committee for Medicinal Products for Human Use will make Remicade ? the brand name for infliximab – the only biologic treatment approved in the EU for paediatric Crohn’s disease.

The EU decision follows on from approval for Remicade in cases of conventional treatment-resistant paediatric Crohn’s disease in the USA in May 2006.

“This positive opinion is significant for Remicade as it will be the first biologic therapy available to children suffering with Crohn’s disease in the EU,” said Robert J Spiegel, chief medical officer at Schering-Plough Research Institute.

The CHMP recommendation covers cases of Crohn’s disease in children aged six to 17 years, whose conditions have proven resistant to corticosteroids, immunomodulators and primary nutrition therapies, or who are contraindicated for such treatments.

The recommendation is based on data collected from the phase III REACH trial. 88.4 per cent of patients were found to be in clinical response after ten weeks of treatment, and 58.9 per cent were in clinical remission.

“The CHMP recommendation for infliximab is an important milestone in addressing an unmet need in treating pediatric patients with Crohn’s disease,” said Peter Milla, professor of paediatric gastroenterology and nutrition at Great Ormond Street Hospital.

We currently have 6 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.