Supplemental applications for Simponi Aria filed with FDA for polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis.- Janssen Biotech

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLA) to the FDA seeking approval of Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate. If approved for these indications, Simponi Aria would be the first anti-tumor necrosis factor (TNF)-alpha biologic agent administered by intravenous infusion available for the treatment of these juvenile arthritides. The submissions are based on results from the GO-VIVA Phase III clinical trial, which was an open-label study conducted to assess the pharmacokinetics, safety and efficacy of Simponi Aria in children with pJIA ages two to 17 years who had active arthritis in five or more joints, despite receiving treatment with methotrexate for at least two months. The trial also included patients with jPsA. GO-VIVA was designed to extrapolate data from a pivotal Phase III clinical development program for Simponi Aria. Data extrapolation is the process of estimating future trends or effects based on previous observations. With limited pediatric patients available for clinical trial inclusion, researchers can extrapolate data from adult patient trials to determine the potential efficacy and tolerability of a treatment for the pediatric population.