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Centocor Seeks Expansion of Simponi Label

Centocor Ortho Biotech, Inc. has submitted an sBLA to the FDA to expand the Simponi label to include the inhibition of the progression of structural damage and maintenance of signs and symptoms of active psoriatic arthritis (PsA).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Centocor Ortho Biotech, Inc. has submitted an sBLA to the FDA to expand the Simponi label to include the inhibition of the progression of structural damage and maintenance of signs and symptoms of active psoriatic arthritis (PsA). The application is based on 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.

“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 R&D, Inc. “This marks an important clinical milestone in the continued lifecycle development of Simponi.”

The company also submitted a Simponi sBLA earlier this year seeking to expand the label to include the inhibition of the progression of structural damage in the treatment of moderately to severely active rheumatoid arthritis (RA). Simponi is currently approved as a 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).

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