The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending the approval of an expanded indication for Remicade (infliximab). The expanded indication would include 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 light A (PUVA), Centocor B.V. and Schering-Plough Corporation jointly announced here.

The CHMP recommendation is an important step towards a European Commission approval. A Commission approval of the application will result in Marketing Authorization with unified labeling that will be valid in all EU-member states, including the current 25 member states as well as Iceland and Norway.

The positive opinion for Remicade for psoriasis is primarily based on data from the Spirit (Study of Psoriasis with Infliximab Induction Therapy) and Express (European Infliximab for Psoriasis Efficacy and Safety Study) trials.

Schering-Plough markets Remicade in all countries outside of the United States, except in Japan, China and parts of the Far East where Tanabe Seiyaku, Ltd. markets the product. Centocor, Inc., a wholly owned subsidiary of Johnson & Johnson, has exclusive marketing rights to the product in the United States.