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EU Approves Once-Monthly Golimumab Injection for RA, Psoriatic Arthritis, and Ankylosing Spondylitis NEW YORK -- October 6, 2009 -- The European Commission has approved golimumab (Simponi) as a once-monthly, subcutaneous therapy for the treatment of moderate-to-severe, active rheumatoid arthritis (RA), active and progressive psoriatic arthritis (PsA) and severe, active ankylosing spondylitis (AS). The Commission Decision follows a positive opinion adopted on June 25, 2009, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The efficacy and safety of golimumab has been studied in a phase 3 development program that included more than 2,000 patients living with moderately to severely active RA, active PsA, and active AS. In phase 3 rheumatoid arthritis trials, golimumab was shown to be effective regardless of prior treatment experience, which included patients inadequately responding to methotrexate and patients previously treated with anti-tumour necrosis factor (TNF) agents. The most common adverse drug reaction reported from clinical trials through week 16 was upper respiratory tract infection (7.2%). In controlled phase 3 trials through week 16 in RA, PsA, and AS, 5.8% of golimumab-treated patients had injection site reactions compared with 2.2% in control-treated patients. The majority of the injection site reactions were mild and moderate, and the most frequent manifestation was injection site erythema. SOURCE: Johnson&Johnson E-mail this page to a friend or colleague! To print, use this version