FDA to Review Two New Indications for Simponi Aria
Janssen Biotech announced the submission of two supplemental Biologics License Applications (sBLAs) to the Food and Drug Administration (FDA) for the approval of Simponi Aria (golimumab) to treat adults with active psoriatic arthritis and adults with active ankylosing spondylitis.
The sBLAs included data from two Phase 3 studies that assessed the safety and efficacy of Simponi Aria 2mg/kg infusion every 8 weeks after two starter doses at Weeks 0 and 4 in adults with active psoriatic arthritis (GO-VIBRANT) and active ankylosing spondylitis (GO-ALIVE).
Simponi Aria, a fully human tumor necrosis factor (TNF)-alpha inhibitor, is already approved for use as an intravenous (IV) infusion to treat adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. It works by targeting both soluble and transmembrane bioactive forms of TNF-alpha, a protein that that can cause inflammation and damage to bones, cartilage, and tissue when overproduced. By binding with and blocking TNF-alpha, Simponi Aria helps control inflammation.
Simponi Aria is available as a 50mg/4mL strength solution for IV infusion in single-use vials.