Janssen Biotech submits application to FDA for rheumatoid arthritis drugComtex News Network
Sep 20, 2012 (Datamonitor via COMTEX) --Janssen Biotech, Inc., a Johnson & Johnson company, has announced the submission of a biologics license application to the FDA requesting approval of an investigational intravenous formulation of the anti-tumor necrosis factor, or TNF,-alpha SIMPONI, for the treatment of adults with moderately to severely active rheumatoid arthritis.
The biologics license application is supported by findings from the Phase III 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, or 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 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 three months. 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, 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.
"We are pleased to present the FDA with an application supporting the efficacy and safety of an intravenous formulation of SIMPONI seeking its approval for the treatment of moderately to severely active rheumatoid arthritis," said Jerome Boscia, vice president, head of immunology development, Janssen R&D, LLC. "Upon approval, an intravenous formulation of SIMPONI would offer rheumatologists and people affected by this chronic, immune-mediated inflammatory disease an important new treatment option, in addition to the currently available subcutaneous formulation of SIMPONI."http://www.datamonitor.comRepublication or redistribution, including by framing or similar means,is expressly prohibited without prior written consent. Datamonitor shallnot be liable for errors or delays in the content, or for any actionstaken in reliance thereon