Centocor Ortho Biotech Inc. announced today that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) 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).
SIMPONI received U.S. FDA approval in April 2009 and became the first 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. For the RA indication, SIMPONI is given in combination with the drug methotrexate.
The sBLA is supported by long-term efficacy and safety data from three pivotal Phase 3 registration trials of three diverse moderately to severely active RA patient populations – patients naïve 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.
“This application represents yet another milestone for the SIMPONI clinical development program,” said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor Research & Development, Inc. “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 rheumatoid arthritis.”
Source: Centocor Ortho Biotech Inc.