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news.Centocor Ortho Biotech has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) regarding Simponi (golimumab).
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Centocor has submitted the sBLA seeking to expand the Simponi (golimumab) physician label to include inhibiting the progression of structural damage, inducing major clinical response (MCR) and maintenance of reducing signs and symptoms and improving physical function in the treatment of moderately to severely active rheumatoid arthritis (RA).
Centocor’s sBLA results from the long-term efficacy and safety data of three pivotal Phase 3 registration trials of three diverse moderately to severely active RA patient populations, patients naive to methotrexate, patients who had an inadequate response to methotrexate and patients previously treated with one or more anti-tumor necrosis factor (TNF)-alpha agents.
The FDA has approved Simponi in April 2009 which is a once-monthly anti-tumor necrosis factor (TNF)-alpha therapy approved for the treatment of adults with moderately to severely active RA, active psoriatic arthritis and active ankylosing spondylitis.
Centocor said that for the RA indication, Simponi is given in combination with the drug methotrexate.
Centocor Clinical R&D senior vice president Boscia said that the application represents a milestone for the Simponi clinical development program.
“We look forward to collaborating with the FDA in reviewing the data from our Phase 3 registration trials that support the efficacy of Simponi in inhibiting the progression of structural damage in patients with moderately to severely active RA,” Boscia said.