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 --