BLA Submitted for IV Form of Simponi for Rheumatoid Arthritis

Janssen Biotech announced the submission of a Biologics License Application (BLA) to the FDA requesting approval of an investigational intravenous formulation of Simponi (golimumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).  

The BLA is supported by findings from the Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy (GO-FURTHER) trial, which evaluated the safety and efficacy of intravenously administered Simponi, in combination with methotrexate, via a 30-minute infusion at Weeks 0, 4 and then every eight weeks vs. placebo in 592 adults.  Study participants had been diagnosed with active RA, defined as having at least six tender and six swollen joints, and had been receiving background methotrexate for at least three months.  The primary endpoint of GO-FURTHER was the proportion of patients demonstrating 20% improvement in arthritis signs and symptoms (ACR 20) at Week 14.  Secondary endpoints included a 50% improvement in arthritis signs and symptoms (ACR50) at Week 24, improvements in disease activity and physical function, as measured by the European League Against Rheumatism (EULAR)/Disease Activity Score (DAS) 28-C-reactive protein (CRP) and Health Assessment Questionnaire (HAQ), and inhibition of structural damage, as measured by X-ray. 

Simponi is a human monoclonal antibody that targets and neutralizes excess TNF-α, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.  Simponi is approved for the treatment of moderately to severely active rheumatoid arthritis (RA) with methotrexate, active psoriatic arthritis alone or with methotrexate and active ankylosing spondylitis.  Simponi is available either through the SmartJect autoinjector or a prefilled syringe as a subcutaneously administered injection. 

For more information visit www.janssenrnd.com.