The FDA has approved Simponi (golimumab, from Centocor Ortho Biotech), a human monoclonal antibody, anti-tumor necrosis factor (TNF)-alpha therapy, for the treatment of adults with moderately to severely active rheumatoid arthritis in combination with methotrexate, active psoriatic arthritis alone or in combination with methotrexate, or active ankylosing spondylitis. This approval was based on clinical trial results that demonstrated more patients treated with Simponi plus methotrexate achieved at least a 20% improvement in arthritis symptoms compared to patients treated with placebo plus methotrexate and/or other disease modifying anti-rheumatic drugs.

Simponi is a once-monthly, patient-administered, subcutaneous injection. It will be available in two dosage forms; the Simponi SmartJect autoinjector or a prefilled syringe.

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