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FDA Advisory Committee Recommends Approval of REMICADE® for Treatment of Pediatric Ulcerative Colitis
Date:7/21/2011

n's disease, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, ulcerative colitis (UC), pediatric Crohn's disease and psoriasis.  The safety and efficacy of REMICADE® have been well established in clinical trials over the past 17 years and through commercial experience with more than 1.5 million patients treated worldwide.

In the U.S., REMICADE® is approved for the following indications:

  • Reducing signs and symptoms, inhibiting the progression of structural damage and improving physical function in patients with moderately to severely active RA, when administered in combination with methotrexate.  
  • Reducing signs and symptoms in patients with active ankylosing spondylitis.
  • Reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.  
  • Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease.  
  • Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in patients with moderately to severely active UC who have had an inadequate response to conventional therapy.
  • Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis.  
  • Treatment of adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

REMICADE® is unique among available anti-TNF-alpha biologic therapies.  It is the only anti-TNF-alpha biologic administered directly by caregivers in the clinic or office sett
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SOURCE Janssen Biotech, Inc.
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