Janssen has submitted 2 supplemental Biologics License Applications (sBLA) to the Food and Drug Administration (FDA) for golimumab for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients aged ≥2 years in combination with methotrexate.
The submission is based on data from the multicenter, open-label, single arm phase 3 GO-VIVA trial that evaluated the efficacy, safety and pharmacokinetics of golimumab in 127 patients aged 2 to 17 years with pJIA who had active arthritis in ≥5 joints, despite receiving methotrexate for ≥2 months. Patients with jPsA were also included in the trial.
The study, which was conducted as part of a postmarketing requirement under the Pediatric Research Equity Act, was designed to estimate the potential efficacy and tolerability of golimumab in pediatric patients by extrapolating data from the pivotal phase 3 clinical program (GO-FURTHER and GO-VIBRANT) of golimumab in adult patients with rheumatoid arthritis and psoriatic arthritis, respectively.
Golimumab, a tumor necrosis factor (TNF) blocker, is currently marketed under the brand name Simponi Aria® and is indicated for the treatment of adults with active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active rheumatoid arthritis in combination with methotrexate.
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