Janssen Biotech submit application to FDA for Simponi as treatment for adults with active Rheumatoid Arthritis

Janssen Biotech has submitted a Biologics License Application (BLA) to the FDA requesting expanded approval for an intravenously delivered form of Simponi (golimumab) for the treatment of adults with moderately to severely active Rheumatoid Arthritis. This is supported by findings from the Phase III trial of Simponi, the GO-FURTHER study, 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 compared with placebo in 592 adults.

The primary endpoint of GO-FURTHER is the proportion of patients demonstrating 20 percent improvement in arthritis signs and symptoms (ACR 20) at week 14. Secondary endpoints include a 50 percent improvement in arthritis signs and symptoms (ACR50) at week 24, improvements in disease activity and physical function, and inhibition of structural damage, as measured by X-ray. Long-term data, including signs and symptoms, structural damage and safety analyses, will be submitted for presentation at a medical congress in the future. The FDA approved Simponi for RA delivered subcutaneously in 2009 so this new approval would broaden treatment options for doctors. An application requesting approval of an intravenous formulation of Simponi for the treatment of moderately to severely active RA is currently under review in the European Union.