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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 a...

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