Janssen Requests FDA Approval of IV Simponi (Golimumab) for RA
Drug currently available as subcutaneous injection (Sept. 18)
Janssen Biotech, Inc., based in Horsham, Pa., announced on September 18 that the company has submitted a Biologics License Application (BLA) to the FDA requesting approval of an investigational intravenous formulation of the anti-tumor necrosis factor (TNF)-alpha monoclonal antibody Simponi (golimumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
An estimated 1.5 million Americans have RA, a chronic autoimmune disease that causes pain, stiffness, and inflammation in the joints, and may lead to irreversible joint damage.
The BLA is supported by findings from the phase III randomized, double-blind, placebo-controlled GO-FURTHER (Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy) trial, which evaluated the safety and efficacy of intravenously administered Simponi, in combination with methotrexate, via a 30-minute infusion at weeks 0 and 4 and then every 8 weeks compared with 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 3 months. The primary endpoint of the GO-FURTHER trial was the proportion of patients demonstrating 20% improvement in arthritis signs and symptoms (ACR20) at week 14. Secondary endpoints include 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); and inhibition of structural damage, as measured by X-ray.
Signs and symptoms at week 24, physical function, and safety results from the study were presented at the 2012 EULAR Annual Congress, and the study was published in the June 2012 issue of Annals of the Rheumatic Diseases. Long-term data, including signs and symptoms, structural damage, and safety analyses, will be submitted for presentation at a medical congress in the future.
Simponi is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, 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 in 57 countries for adult rheumatologic indications, including the U.S., where the drug received FDA approval in April 2009 for the treatment of moderately to severely active RA in combination with methotrexate; for the treatment of active psoriatic arthritis alone or with methotrexate; and for the treatment of active ankylosing spondylitis. Simponi is currently available through either the SmartJect autoinjector or a prefilled syringe as a subcutaneously administered injection.
Simponi is also being investigated in phase III studies as a subcutaneously administered treatment for active polyarticular juvenile idiopathic arthritis (JIA).
For more information, visit the Johnson & Johnson Web site.