The new indication includes the treatment of moderate to severe plaque psoriasis in adults who have failed to respond to other systemic therapy. The European Commission approval results in marketing authorization with unified labeling valid in all European member states as well as Iceland and Norway.
This approval follows a positive opinion granted on July 28, 2005 by the European Union’s Committee for Medicinal Products for Human Use (CHMP), for the European Agency for the Evaluation of Medicines Agency (EMEA).
Plaque psoriasis, is a chronic, immune-mediated disease, which can cause severe physical discomfort and have a significant impact on a person’s quality of life.
“This approval reinforces the broad clinical utility of Remicade, which is now indicated in the treatment of Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis and has been used to treat more than 600,000 patients worldwide,” said Dr Robert Spiegel, chief medical officer and senior vice president of medical affairs for Schering-Plough Research Institute.