EU label extension for S-P's Remicade

The European Commission has approved a label extension for US drug major Schering-Plough's 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 (CHMP) 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, halving the infusion time. Shortened infusions at doses greater than 6mg/kg have not been studied, S-P noted.