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Simponi Aria is now approved to to treat patients 2 years and older with active polyarticular juvenile Idiopathic arthritis (pJIA) and psoriatic arthritis (PsA).
FDA expanded the indication for the rheumatoid arthritis (RA) medication golimumab (Simponi Aria, Janssen) to treat patients 2 years and older with active polyarticular juvenile Idiopathic arthritis (pJIA) and psoriatic arthritis (PsA).
Simponi Aria is already approved Ito treat adults with moderately to severely active RA, active PsA, and active ankylosing spondylitis (AS).
“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,” said Mathai Mammen, MD, PhD, global head of Janssen Research & Development at Johnson & Johnson, in a press release.
“For far too long, children with pJIA or PsA have had limited treatment options,” said Seth D. Ginsberg, co-founder and president of the Global Healthy Living Foundation and CreakyJoints. “This approval represents an important step forward for these children and their families.”
The approval was based on results from the GO-VIVA Phase 3 clinical trial, an open-label study in children with JIA with active polyarthritis. The children, ages 2 to 17 years old, had active arthritis in five or more joints despite receiving treatment with methotrexate for at least 2 months.
Trial results demonstrated that Simponi Aria was generally consistent with responses in adult patients with RA.
Simponi Aria is a fully human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of human TNFalpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation.