FDA Approves Updated Labeling for Simponi Aria
Janssen Biotech announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the label for Simponi Aria (golimumab for infusion) to include measures in both physical and emotional health in patients being treated for moderately to severely active rheumatoid arthritis (RA).
The updated label includes data from the GO-FURTHER trial, a randomized, multicenter, double-blind, placebo-controlled study of 592 adults with RA who were assigned to receive IV placebo or Simponi Aria 2mg/kg infusions at Week 0, Week 4, Week 12, and Week 20. All patients continued stable oral methotrexate (15–25mg per week). Patient-reported outcomes in the Medical Outcomes Study Short Form-36 questionnaire (SF-36) showed that patients receiving Simponi Aria plus methotrexate demonstrated greater improvement from baseline compared with placebo and methotrexate in all areas of SF-36 at Weeks 12, 16 and 24 (physical component summary [PCS] scores and mental component summary [MCS] scores).
Simponi Aria is indicated for the treatment of moderately to severely active RA and is the only intravenous anti-tumor necrosis factor (TNF)-alpha administered as a 30-minute infusion. Phase 3 studies are ongoing to seek approval for additional indications for Simponi Aria.
For more information call (800) 526-7736 or visit SimponiAria.com.