Centocor Ortho Biotech Inc. has submitted a supplemental Biologics License Application to the FDA to expand the Simponi (golimumab) physician label.
The company seeks to have the label 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).
The drug received 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. Simponi is a human monoclonal antibody that targets and neutralizes excess TNF-alpha. When TNF-aplha, a protein, is overproduced in the body due to chronic inflammatory diseases it can cause inflammation and damage to bones, cartilage and tissue
For the RA indication, Simponi is given in combination with the drug methotrexate.
RA is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction, and disability. More than one million Americans are living with the disease and it affects mostly women.
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, in a press release. “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.”
Centocor Ortho Biotech Inc. also has products for the following medical specialties: dermatology, gastroenterology, nephrology, oncology, rheumatology, surgery, and virology. The company was created in 2008 and harnesses innovations in large-molecule and small-molecule research to create therapeutic options, with a main focus in immunology, nephrology, and oncology. The company also produces Remicade, which is a biologic that blocks the action of TNF. Remicade can be used in combination with methotrexate to treat active rheumatoid arthritis.