FDA ACCEPTS APPLICATION REQUESTING APPROVAL OF REMICADE

Centocor has announced that the FDA has accepted its filing of a supplemental biologics license application (sBLA) for the use of Remicade (infliximab) in the treatment of moderate-to-severe plaque psoriasis. It is estimated that nearly two million Americans suffer from moderate-to-severe psoriasis, a chronic, immune-mediated inflammatory disease that can be both physically and emotionally debilitating.

The acceptance of the sBLA file for psoriasis follows the September 2005 European Commission approval of Remicade for 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 light A.