EU approves Remicade label update for CD

USA-based drugmaker Schering-Plough says that the European Commission has approved a label change for the firm's antibody-based therapeutic Remicade (infliximab). The update, which states that the agent can be used as a second-line treatment for severe, active Crohn's disease in patients who have not responded to corticosteroid and/or immunosuppression-based therapy, follows a positive opinion on the indication change from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use in July this year.

Previously Remicade, which was developed in a collaboration between S-P and fellow US firm Centocor, held European approval for the third-line treatment of the condition. The reclassification was based on data from the ACCENT 1 and GETAID studies, which demonstrated that the drug allowed a higher percentage of patients to achieve clinical remission when used either as maintenance therapy or in combination with azathioprine or 6-mercatopurine. In addition, the long-term safety data provided by the TREAT registry bolstered the CHMP's approval of the agent as a second-line therapy for this patient group.

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