BRIEF—FDA approval for pediatric use in active pJIA and PsA for Simponi Aria

30 September 2020

Today the Food and Drug Administration has approved SIMPONI ARIA (golimumab), from Johnson & Johnson subsidiary Janssen, for patients two years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population.

Simponi Aria is the first and only fully human anti-tumor necrosis factor (TNF)-alpha biologic agent administered by intravenous infusion approved for pediatric use in both active pJIA and active PsA.
The approval was based on results from the GO-VIVA Phase III clinical trial, an open-label study in children with JIA with active polyarthritis ages two to 17 years who had active arthritis in five or more joints, despite receiving treatment with methotrexate for at least two months. Trial results demonstrated that pharmacokinetic (PK) exposure of Simponi Aria was consistent with that of two pivotal Phase III clinical trials of the drug in adult patients with moderately to severely active rheumatoid arthritis (RA) and active PsA.
The polyarticular form of JIA is most common and is characterized by inflammation in more than four joints and resembles adult RA. PsA in pediatric patients is one of the rarest subtypes of JIA and is characterized by both joint inflammation and skin lesions associated with psoriasis resembling adult PsA.

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