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FDA to
review the submission for golimumab
and methotrexate (MTX) combination as a treatment for pJIA and jPsA.
Recently, two supplemental Biologics License Applications (sBLA) were presented to the FDA by a renowned pharmaceutical company for golimumab to be used in combination with methotrexate for polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA) treatment in patients aged more than or of 2 years.
The data for this presentation is based on the phase, GO-VIVA trial. In this study the safety, efficacy and pharmacokinetics of golimumab (tumor necrosis factor (TNF) blocker) was determined. In this trial, a total of 127 patients with age groups between 2-17 years who had pJIA were included. In these patients active arthritis was observed in ≥5 joints, in spite of taking methotrexate for more than or just about 2 months. The jPsA patients were also involved.
As part of a post-marketing prerequisite considering the Pediatric Research Equity Act, the study was performed with an aim to evaluate the possible overall effectiveness of golimumab in pediatric patients. The data was deduced from the pivotal GO-FURTHER and GO-VIBRANT trials of golimumab in adults with rheumatoid arthritis (RA) and psoriatic arthritis (PsA).
Jenssen
Golimumab Juvenile Arthritis Study Data Submitted for FDA Review
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