Centocor Inc. and Schering-Plough Corporation have been granted approval for Remicade (infliximab) for the treatment of moderate to severe plaque psoriasis by the European Commission.
According to the company release, the new indication includes the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapy including cyclosporine, methotrexate or psoralen plus ultraviolet A light (PUVA). This approval follows a positive opinion granted on July 28, by the European Union's (EU) Committee for Medicinal Products for Human Use (CHMP), for the European Agency for the Evaluation of Medicines Agency (EMEA).
The Commission approval results in marketing authorisation with unified labeling valid in all EU-member states, including the current 25 member states as well as Iceland and Norway. The approval of Remicade for the treatment of psoriasis is primarily based on data from the SPIRIT (Study of Psoriasis with Infliximab [Remicade] Induction Therapy) and EXPRESS (European Infliximab for Psoriasis [Remicade] Efficacy and Safety Study) trials.
"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 6,00,000 patients worldwide," said Robert J. Spiegel, chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.
Psoriasis is a chronic, immune-mediated disease caused when skin cells over-produce and accumulate on the surface causing red, scaly plaques that may itch and bleed. The most common form of psoriasis, 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.