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Centocor Ortho Biotech Inc. Submits Application to FDA Seeking to Expand SIMPONI® Label to Include Inhibition of Structural Damage in Treatment of Psoriatic Arthritis
Date:11/11/2010

HORSHAM, Pa., Nov. 11, 2010 /PRNewswire/ -- Centocor Ortho Biotech Inc. has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking to expand the SIMPONI® physician label. The sBLA includes inhibition of the progression of structural damage and maintenance of improvement in signs and symptoms and physical function in the treatment of patients with active psoriatic arthritis (PsA).  

This submission represents the second sBLA submission for SIMPONI in 2010.  In September 2010, Centocor Ortho Biotech submitted a sBLA seeking to expand the SIMPONI label to include the inhibition of the progression of structural damage in the treatment of moderately to severely active rheumatoid arthritis (RA).  In April 2009, SIMPONI received U.S. FDA approval as the first once-monthly anti-tumor necrosis factor (TNF)-alpha therapy for the treatment of adults with moderately to severely active RA, active PsA, and active ankylosing spondylitis (AS).  

"This application seeks to expand the SIMPONI label to include inhibiting the progression of structural damage, a potentially devastating manifestation sometimes associated with active psoriatic arthritis," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor Research & Development, Inc.  "This marks an important clinical milestone in the continued lifecycle development of SIMPONI."

The sBLA is supported by data from the (Golimumab – A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody) GO-REVEAL study, which evaluated the safety and efficacy of SIMPONI in patients with active PsA.

About Psoriatic Arthritis

Psoriatic arthritis is a chronic inflammatory disease that causes joint pain and swelling, skin symptoms and can lead to joint destruction. 
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SOURCE Centocor Ortho Biotech Inc.
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