Delayed adverse events with Remicade
While Centocor Inc. recently reported positive Phase III data for its Remicade infliximab chimeric monoclonal antibody against tumor necrosis factor in rheumatoid arthritis, Phase IV testing in Crohn's disease has revealed delayed adverse events associated with retreatment using the MAb.
The adverse events prompted a "Dear Doctor" warning letter from CNTO and the suspension of one Phase IV trial. The company hopes that retreatment safety concerns arising from this study will not negatively affect review of Remicade's BLA in RA, which is expected to be submitted to FDA by early 1999.
In conjunction with its FDA advisory panel meeting in May and approval of Remicade in Crohn's disease in August, CNTO committed to conducting Phase IV studies of the intravenous biologic in juvenile patients with Crohn's and to examine retreatment or maintenance therapy in