Schering-Plough Corporation announced that the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has issued a positive opinion recommending approval of expanded labeling for Remicade (infliximab) to include maintenance dosing for sustaining clinical response in patients with fistulizing, active Crohn's disease who have responded to infliximab therapy.

The CPMP recommendation serves as the basis for a European Commission approval. A Commission approval of the application will result in Marketing Authorization with unified labeling that will be valid in all 15 EU-Member states as well as in Iceland and Norway.

In May, the EU approved Remicade for maintenance dosing for the treatment of patients with severe, active Crohn's disease who have responded to infliximab therapy. Remicade is the only biologic indicated for the treatment of CD, rheumatoid arthritis (RA) and ankylosing spondylitis (AS), a serious inflammatory disease that leads to stiffening and subsequent fusion of the spine. Remicade is the worldwide market leader among TNF-alpha therapies, with more than 400,000 patients treated.

The CPMP positive opinion for Remicade maintenance dosing in fistulizing, active Crohn's disease, a serious gastrointestinal disorder, is based on data from the ACCENT II trial, a one-year trial that evaluated the safety and effectiveness of Remicade as a maintenance therapy for fistulizing active CD. The study results demonstrated the ability of Remicade to induce and maintain closure of draining fistulas.

In the EU, Remicade is indicated for the treatment of severe, active Crohn's disease in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant or who are intolerant to or have medical contraindications for such therapies. Remicade is also indicated for the treatment of fistulizing Crohn's disease in patients who have not responded despite a full and adequate course of therapy with conventional treatment, including antibiotics, drainage and immunosuppressive therapy.

For RA patients, Remicade, in combination with methotrexate, is indicated for use for the reduction of signs and symptoms and the improvement in physical function in patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate. In this patient population, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated.

For AS patients, Remicade is approved for use in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.

Remicade is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha. Overproduction of TNF-alpha is believed to play a role in RA, CD and AS, and may also be important in a wide range of other immune-mediated inflammatory disorders.