Remicade Receives Approval in European Union for Shortened Infusion Time in Patients w/ RA

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Remicade Receives Approval in European Union for Shortened Infusion Time in

Patients With Rheumatoid Arthritis

http://www.prnewswire.co.uk/cgi/news/release?id=186708

Centocor, Inc. and Schering-Plough Corporation today announced that the

European Commission (EC) has approved a label extension for REMICADE®

(infliximab) allowing for a shortened infusion time in patients with

rheumatoid arthritis (RA). 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.

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 time. Shortened

infusions at doses greater than 6 mg/kg have not been studied.

" This is welcome news for European rheumatologists who regularly manage

rheumatoid arthritis patients, " said Emery, MD, Arthritis Research

Campaign Professor and Head of Academic Medicine, University of Leeds. " This

label change will provide physicians and their patients with a new option in

the treatment of this debilitating disease. "

" This latest regulatory action further validates the safety and efficacy

profile of REMICADE for the treatment of patients with rheumatoid

arthritis, " said Spiegel, MD, chief medical officer and senior vice

president, Schering-Plough Research Institute. " The European Commission

approval represents greater convenience for rheumatoid arthritis patients,

physicians and their staffs with a new option to shorten the infusion time

for REMICADE. "

The EC approval of the shortened infusion time 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 control study involving 1,040 patients

with RA. The study 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 percent of patients and serious

infusion reactions occurred in 0.4 percent of patients.