Centocor and S-P submit MAA on golimumab

US drugmakers Centocor (J&J) and Schering-Plough have submitted a Marketing Authorization Application 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 III development programs are unprecedented among anti-tumor necrosis factor-alpha therapies, as they mark the first time that an MAA has been proposed for review inclusive of three unique disease states, the firms noted. The next-generation human anti-TNF-alpha antibody is being studied as a subcutaneous injection used every four weeks and an intravenous (IV) infusion therapy, the firms noted.