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This approval makes the drug the first of its kind to treat polyarticular juvenile idiopathic arthritis and psoriatic arthritis in a pediatric population.
The US Food and Food Drug Administration (FDA) has approved golimumab (SIMPONI ARIA) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients ≥2 years of age.
Furthermore, the FDA has extended its indication for psoriatic arthritis, one of the rarest subtypes of JIA, in that same population.
This makes it the first and only human anti-tumor necrosis factor (TNF)-alpha biologic agent administered by intravenous infusion approved for pediatric use in treating both conditions.
Granted to Janssen Pharmaceutical, the approval was based on results from the GO-VIVA Phase 3 clinical trial.
The open-label, single arm, multicenter study was conducted across 9 countries and assessed the efficacy of treatment in children with pJIA aged 2-17 years old. These patients had active arthritis despite receiving treatment with methotrexate for at least 2 months.
Thus, the results of the trial showed that pharmacokinetic exposure of SIMPONI ARIA was consistent with results from 2 other pivotal Phase 3 clinical trials of the drug, which evaluated treatment in adult patients with moderately to severely active rheumatoid arthritis and psoriatic arthritis.
Efficacy and safety profiles, assessed through week 52, were generally similar between the pediatric patient population of the GO-VIVA trial and adult patients.
Common side effects of the therapy include upper respiratory infection, abnormal liver tests, decreased infection-fighting blood cells, viral infectors, bronchitis, high blood pressure and rash.
Additionally, the indication cautions that the medication can lower one’s ability to fight infections. It also may increase risk for other conditions such as cancer and heart failure.
"For far too long, children with pJIA or PsA have had limited treatment options," said Seth Ginsberg, Co-Founder and President of the Global Healthy Living Foundation and CreakyJoints in a statement. “This approval represents an important step forward for these children and their families."