Centocor, Inc, and its marketing partner, Schering-Plough Corporation, have announced that the European Commission has granted approval of Remicade® (infliximab) for the treatment of moderate-to-severe plaque psoriasis. The global market leader among anti-tumor necrosis factor-alpha (TNF-α) therapies, infliximab is also indicated for adults who failed to respond to, have a contraindication to, or are intolerant of other systemic therapies including cyclosporine, methotrexate, or psoralen plus ultraviolet A light. The unified labeling is valid in all 25 EU member states as well as Iceland and Norway.
The approval of infliximab for the treatment of psoriasis is based primarily on data from the large multicenter, randomized, double-blind, placebo-controlled SPIRIT (Study of Psoriasis with Infliximab [Remicade] Induction Therapy) and EXPRESS (European Infliximab for Psoriasis [Remicade] Efficacy and Safety Study) trials. The primary efficacy endpoint in both studies was at least 75% improvement in the Psoriasis Severity Index (PASI) score from baseline at week 10.
Infliximab has already been approved in Europe to treat rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriatic arthritis, but has not yet been approved in the US for the treatment of psoriasis. So far, more than 600,000 patients worldwide have been treated with infliximab.
A leader in biologic therapies, Centocor, a wholly owned subsidiary of Johnson & Johnson, has exclusive marketing rights to the product in the US. Schering-Plough markets infliximab in all countries outside the US except Japan and parts of Asia and China where Tanabe Seiyaku, Ltd, and Xian-Janssen market the product.
—A. Techman