The FDA has approved Simponi Aria (golimumab) for the treatment of active pJIA for patients two years of age and older and has extended the PsA indication for this same patient population. In Phase 3 clinical trials with pediatric patients, pharmacokinetic (PK) exposure of Simponi Aria, from the Janssen Pharmaceutical Companies of Johnson & Johnson, was consistent with that of two pivotal Phase 3 clinical trials of Simponi Aria in adult patients with moderately to severely active RA and active PsA.
"This latest FDA approval of Simponi Aria for pediatric use in active pJIA and active PsA not only brings a new option to young patients living with these diseases but also adds to the growing body of evidence for this treatment," says Mathai Mammen, MD, PhD, Global Head, Janssen Research & Development, Johnson & Johnson. "For more than 20 years, we at Janssen have been committed to researching anti-TNF biologic agents for immune-mediated diseases and are encouraged to expand treatment options for these patients."
Approval was based on results from the GO-VIVA Phase 3 clinical trial, an open-label study in children with JIA with active polyarthritis ages two o 17 years who had active arthritis in five or more joints, despite receiving treatment with methotrexate for at least two months. Efficacy was assessed as supportive endpoints through Week 52. The efficacy was generally consistent with responses in adult patients with RA. The adverse reactions observed in GO-VIVA were consistent with the established safety profile of SIMPONI ARIA in adult patients with RA and PsA..
Janssen CarePath offers a comprehensive support program that helps patients get started on Simponi Aria and remain on therapy. Janssen CarePath provides information on insurance coverage, potential out-of-pocket costs and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible.