CENTOCOR WINS ADDITIONAL FDA APPROVAL FOR REMICADE

Centocor announced that the FDA has extended its approval for Remicade (infliximab) for inhibiting progression of structural damage and improving physical function in patients with psoriatic arthritis, in addition to reducing signs and symptoms of active arthritis. The approval is based on one-year data from the double-blind, placebo-controlled IMPACT 2 trial and two-year data from the double-blind, placebo-controlled IMPACT trial.

Trial findings showed that at week 24, Remicade-treated patients had less structural damage as assessed radiographically compared with patients receiving placebo, and Remicade-treated patients were more than twice as likely to achieve a clinically meaningful improvement in physical function compared with patients receiving placebo.

The drug is the global market leader among anti-tumor necrosis factor alpha therapies and has demonstrated broad clinical utility in Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis and pediatric Crohn's disease.