Centocor, Inc., announced today that the U.S. Food and Drug Administration (FDA) has accepted its filing of a supplemental Biologics License Application (sBLA) for
REMICADE® (
infliximab) as first-line therapy, in combination with methotrexate, for the treatment of early
rheumatoid arthritis (RA) patients with moderately-to-severely active disease. REMICADE®, in combination with methotrexate, is currently indicated in the U.S. for reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately-to-severely active RA who have had an inadequate response to methotrexate alone.
REMICADE® is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies, the only agent approved for the treatment of both RA and Crohn's disease in North America, the European Union and Japan, and was the first biologic approved for ankylosing spondylitis (AS) in the European Union.
The submission is based on the results of the ASPIRE (Active Controlled Study of Patients Receiving Infliximab for Treatment of Rheumatoid Arthritis of Early Onset) trial. In this trial, REMICADE® plus methotrexate was superior to the gold standard of methotrexate alone in the treatment of early RA patients who were methotrexate-naive. REMICADE® plus methotrexate was superior to methotrexate alone in inhibiting the progression of structural damage, preventing bone erosions, improving physical function and improving clinical symptoms. To date, no anti-TNF monotherapy or combination strategy has been proven superior to methotrexate alone in a clinical study comprised exclusively of early RA patients.
"Increasingly, clinical evidence supports that earlier therapy for RA may enhance patient benefit. This submission for REMICADE® represents Centocor, Inc.'s, continued leadership and commitment to advancing research that we believe may ultimately provide meaningful benefit to patients with early RA," said Jerome A. Boscia, M.D., senior vice president, clinical R&D, Centocor, Inc.
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