SIMPONI(TM) (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing S... ( First Subcutaneous Anti-TNF to Launch...)

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SIMPONI(TM) (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Date:4/24/2009

First Subcutaneous Anti-TNF to Launch with Three Rheumatic Indications Simultaneously and with Novel SmartJect(TM) Autoinjector

HORSHAM, Pa., April 24 /PRNewswire/ -- Centocor Ortho Biotech Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI (golimumab) for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. SIMPONI is the first patient-administered anti-tumor necrosis factor (TNF)-alpha therapy that offers an effective once-monthly treatment option. Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are chronic inflammatory diseases that result in pain and inflammation, and in some cases, joint destruction and disability. These diseases affect more than three million Americans combined.

(Photo: http://www.newscom.com/cgi-bin/prnh/20090424/PH05126 )

"SIMPONI has been studied in a broad range of patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis who had previously received a wide variety of treatments, including adults with rheumatoid arthritis previously treated with anti-TNF therapies, and has been shown to be significantly effective in reducing the signs and symptoms of each of these diseases," said Jonathan Kay, MD, Associate Clinical Professor of Medicine, Harvard Medical School and lead study investigator. "The approval of SIMPONI offers rheumatologists an effective new anti-TNF therapy for patients living with rheumatic diseases."

In the U.S., SIMPONI is approved as a 50 mg subcutaneous injection once a month and is indicated:

In combination with methotrexate for the treatment of adult patients with
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SIMPONI(TM) (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing S...( First Subcutaneous Anti-TNF to Launch...),Health