EC approves label extension for Remicade

US drugmakers Centocor and Schering-Plough say that the European Commission has approved a label extension for Remicade (infliximab) allowing for a shortened infusion time in patients with rheumatoid arthritis. The EC approval follows a positive opinion by the Committee for Medicinal Products for Human Health of the European Medicines Agency (EMEA) received in September 2006.

The shortened infusion time label extension will allow carefully selected patients with RA who have tolerated three initial two-hour infusions of Remicade to be administered subsequent infusions over a one-hour period. This is half the time of the current recommended infusion period. The firms noted that shortened infusions at doses greater than 6mg/kg have not been studied.

The EC approval is based on data from the ASPIRE (Active Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset) trial, a 54-week, randomized, double-blind, placebo-controlled study involving 1,040 patients with RA, which found that, of the infliximab-treated patients who received at least one shortened infusion of 90 minutes or less, infusion-related reactions occurred in 15% of patients and serious infusion reactions in 0.4% of subjects, the companies noted.