Centocor, Inc. and Schering-Plough Corporation announced that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMEA) requesting the approval of golimumab (CNTO 148) as a monthly subcutaneous treatment for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. The initial submission and phase 3 development programmes are unprecedented among anti-tumour necrosis factor (TNF)-alpha therapies, as they mark the first time that an MAA has been proposed for review inclusive of three unique disease states.
Golimumab, Centocor's and Schering-Plough's next-generation human anti-TNF-alpha monoclonal antibody, is being studied as an every four week subcutaneous injection and an intravenous (IV) infusion therapy. Pending regulatory approval in the European Union, Schering-Plough Corporation will assume exclusive marketing rights for golimumab in Europe.
"We look forward to working with the EMEA so that patients and physicians might one day have the opportunity to experience golimumab as a therapeutic option for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis," said Jerome A. Boscia, M.D., senior vice president, Clinical Research and Development, Centocor, Inc. "We remain focused and on track for global regulatory submissions for golimumab targeted for the first half of 2008."
Phase 3 primary endpoint study findings from the Golimumab - A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial and the Golimumab - A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks (GO-RAISE) trial were reported at the American College of Rheumatology Annual Scientific Meeting in November 2007. Phase 3 study findings evaluating the efficacy and safety of golimumab in the treatment of more than 1,400 adults with moderate to severe rheumatoid arthritis will be presented at the European League Against Rheumatism Annual Congress in June 2008.
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumour necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as an every four week subcutaneous injection and an intravenous (IV) infusion therapy. Golimumab targets and neutralizes both the soluble and membrane-bound forms of TNF-alpha.
Centocor discovered golimumab and has exclusive marketing rights to the product in the United States. Pending regulatory approval, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China where golimumab will be exclusively marketed by Xian-Janssen.
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of adult and pediatric Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis and psoriasis.