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news.Centocor Ortho Biotech has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) seeking to expand the Simponi physician label.
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Centocor Ortho Biotech said that 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).
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).
Centocor Ortho Biotech claimed that in April 2009, Simponi received US 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).
Centocor Ortho Biotech’s Simponi sBLA is supported by data from the (Golimumab – A Randomised 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.
Centocor Research & Development Clinical R&D senior vice president Jerome Boscia said that the 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.