-- In June 2002, REMICADE became the first TNF-alpha inhibitor approved
by the FDA for maintenance therapy in patients with moderate to severe
Crohn's disease. And in April 2003, it became the first TNF-alpha
inhibitor approved for maintenance therapy of fistulising Crohn's
-- In May 2003, REMICADE became the first TNF-alpha inhibitor approved in
the EU for the treatment of ankylosing spondylitis in patients who
have severe axial symptoms, elevated serological markers of
inflammatory activity and who have responded inadequately to
-- In October 2004, REMICADE became the first TNF-alpha inhibitor
approved for the treatment of active and progressive psoriatic
arthritis in patients who have responded inadequately to disease
modifying anti-rheumatic drug therapy.
-- In September 2005, the FDA approved REMICADE as the first and only
biologic for reducing signs and symptoms, achieving clinical remission
and mucosal healing and eliminating corticosteroid use in adults with
moderately to severely active UC who have had an inadequate response
to conventional therapy. The FDA extended the indication to include
maintenance therapy for UC in October 2006.
-- In March 2006, REMICADE became the first biologic therapy approved to
treat moderately to severely active UC in the European Union (EU), in
patients with an inadequate response to conventional therapy,
including corticosteroids and 6-MP or AZA, or those intolerant to or
contraindicated for such therapies.
-- In May 2006, REMICADE became the first and only biologic indicated to
reduce signs and symptoms and induce and maintain clinical remission
in pediatric patients with moderately to
|SOURCE Centocor, Inc.|
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