FDA grants label revision for Simponi Aria (golimumab for infusion) in rheumatoid arthritis-Janssen Biotech

Janssen Biotech announced the approval of a FDA Supplemental Biologics License Application (sBLA) for Simponi Aria (golimumab for infusion) for the treatment of moderately to severely active rheumatoid arthritis (RA) to include measures of physical and mental health reported by patients through the Medical Outcomes Study Short Form-36 questionnaire (SF-36). According to the revised label, Simponi Aria, when administered in combination with methotrexate (MTX), improved patients' physical and emotional well-being as measured by the SF-36 assessment.

Comment:Simponi Aria received U.S. FDA approval in July 2013 for the treatment of moderately to severely active RA and is the only intravenous anti-tumor necrosis factor (TNF)-alpha administered as a 30-minute infusion.