European Union Approves REMICADE® For Broader Indication in Treatment of Rheumatoid Arthritis

06-Feb-2001

Schering-Plough Corporation and Centocor, Inc., today announced that the European Union's (EU) Commission of the European Communities has granted marketing authorization to REMICADE® (infliximab) with methotrexate for the improvement in physical function of patients with rheumatoid arthritis and a reduction in the rate of the progression of joint damage when the response to disease-modifying drugs, including methotrexate, has been inadequate.

Commission approval of the centralized Type II variation for REMICADE® results in a single Marketing Authorization with unified labeling that is immediately valid in all 15 EU-Member States. The approval follows a positive recommendation by the EU's Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) in October 2000.

Roch F. Doliveux, president, Schering-Plough International, said, "With this approval, REMICADE® is now available for the treatment of three critical aspects of rheumatoid arthritis -- signs and symptoms, improvement in physical function and a reduction in the rate of joint damage -- providing patients with an immediate benefit by reducing pain and increasing physical function. The positive clinical outcomes demonstrated with REMICADE® show that treating rheumatoid arthritis patients with this therapy can provide a substantial benefit to sufferers of this debilitating disease and to society in terms of lost productivity," he added.

REMICADE® is currently marketed in the EU for rheumatoid arthritis, following the European Commission granting centralized marketing authorization in June 2000 to REMICADE® with methotrexate for the reduction of the signs and symptoms of rheumatoid arthritis in patients with active disease when the response to disease-modifying drugs, including methotrexate, has been inadequate. REMICADE® is also marketed in the EU for the treatment of Crohn's disease, a serious gastrointestinal disorder.

Centocor has exclusive marketing rights to REMICADE® in the United States. Schering-Plough has rights to market REMICADE® in all other countries throughout the world, except in Japan and parts of the Far East where the product will be marketed by Tanabe Seiyaku, Ltd.

The centralized Type II variation application for REMICADE® for the improvement of physical function and the reduction in the rate of the progression of joint damage in rheumatoid arthritis patients is based on 54-week and 102-week radiographic (x-ray) data from ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy), a double-blind, placebo-controlled, randomized clinical trial involving 428 patients at 34 clinical sites in North America and Europe. Structural joint damage (erosions and joint space narrowing) in both hands and feet was measured by the change from baseline in the total van der Heijde-modified Sharp score (0-440). The Health Assessment Questionnaire (HAQ; scale 0-3) was used to measure patients' average change from baseline scores over time in physical function. Based on x-ray data from the ATTRACT trial, a reduction in the rate of the progression of structural joint damage was observed in all infliximab groups at 54 weeks. The effects observed at 54 weeks were maintained through 102 weeks.

ATTRACT, one of the largest clinical studies ever conducted in patients with advanced rheumatoid arthritis, studied the safety and efficacy of REMICADE® at 30, 54 and 102 weeks. All treated patients had active disease despite methotrexate treatment. At week 54, a higher percentage of patients in all infliximab-treated groups had a significant reduction in signs and symptoms compared with methotrexate alone. This response was seen as early as two weeks and was maintained through 102 weeks of treatment. The approved dose is for the lowest dose studied in ATTRACT --

https://www.chemeurope.com/en/news/1179/european-union-approves-remicade-for-broader-indication-in-treatment-of-rheumatoid-arthritis.html