The US Food and Drug Administration (FDA) has approved Simponi Aria (golimumab) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) among patients aged 2 years or older. The FDA has also extended Simponi Aria’s psoriatic arthritis (PsA) indication to include patients aged 2 years or older.
According to a press release from Janssen, Simponi Aria is the first fully human anti-tumor necrosis factor-α biologic agent administered via intravenous (IV) infusion approved for pediatric use in both active pJIA and active PsA.
“For pediatric patients with pJIA and PsA, the Simponi Aria body surface area-based dosage regimen is 80 mg/m2 given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter,” according to the press release.
The new and extended indications were approved after results of the GO-VIVA Phase 3 clinical trial—which included patients aged 2 to 17 years with JIA with active polyarthritis who had active arthritis in 5 or more joints despite receiving treatment with methotrexate for at least 2 months—showed that the biologic is safe and effective among pediatric patients.
The most common adverse effects of Simponi Aria are upper respiratory infection, abnormal liver tests, decreased blood cells that prevent infection, viral infections, bronchitis, hypertension, and rash.
The new indications add to the patient populations for which Simponi Aria has already been approved: adults with moderately to severely active rheumatoid arthritis, adults with active PsA, and adults with active ankylosing spondylitis.
SIMPONI ARIA® (golimumab) approved by the U.S. Food and Drug Administration for active polyarticular juvenile idiopathic arthritis and extension of its active psoriatic arthritis indication in patients 2 years of age and older. News release. Janssen. September 30, 2020. Accessed September 30, 2020. https://www.janssen.com/simponi-aria-golimumab-approved-us-food-and-drug-administration-active-polyarticular-juvenile