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SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
Date:6/26/2009

Positive Opinion Recommends Approval of New Anti-TNF Therapy in Three Rheumatic Diseases with Novel SmartJect(TM) Autoinjector

HORSHAM, Pa. and KENILWORTH, N.J., June 26 /PRNewswire-FirstCall/ -- Centocor Ortho Biotech Inc. and Schering-Plough Corporation (NYSE: SGP) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion recommending the approval of SIMPONI(TM) (golimumab) 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).

Upon Commission approval in the European Union, SIMPONI given as a 50 mg subcutaneous injection once a month will be indicated for:

  • In combination with methotrexate, the treatment of moderate-to-severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drug (DMARD) therapy, including methotrexate, has been inadequate. SIMPONI has also been shown to improve physical function in this patient population.
  • Alone or in combination with methotrexate, the treatment of active and progressive PsA in adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has also been shown to improve physical function in this patient population.
  • The treatment of severe, active AS in adult patients who have responded inadequately to conventional therapy.

"With today's decision, SIMPONI moves one step closer to becoming the first once-monthly subcutaneous anti-TNF therapy for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in the European Union," said Jerome A. Boscia, M.D., Senior V
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SOURCE Schering-Plough Corporation; Centocor Ortho Biotech Inc.
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