Posted by Michael Wonder on 03 Sep 2015
U.S. FDA approves update of Simponi Aria (golimumab for infusion) label to include improvement in both physical and emotional measures of health when treating moderately to severely active rheumatoid arthritis
4 September 2015 - Janssen Biotech, Inc. announced today the approval of a U.S. Food and Drug Administration (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. 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.
“Traditional assessments of RA treatments measure joint function and pain, but we as clinicians know that there is much more to this disease. Measuring physical, mental and social function can provide a more comprehensive view of how RA treatment impacts patient lives,” said Dr. Jeffrey Curtis, MD MS MPH, University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology. “According to results from the SF-36 assessment, patients receiving SIMPONI ARIA® and methotrexate showed marked improvement in general health status measures of physical and mental well-being.”
For more details, go to: https://www.janssenbiotech.com/sites/default/files/pdf/Janssen_SIMPONI_ARIA_SF36_Label_Update_Press_Release_09.01.15.pdf
