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Centocor
U.S. FDA expands Remicade psoriatic arthritis indication
September 13th, 2006
Centocor, Inc. announced that the U.S. Food and Drug Administration (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 trial IMPACT 2 and two-year data from the double-blind, placebo-controlled trial IMPACT. Findings from IMPACT 2 showed that at week 24, Remicade-treated patients had less structural damage as assessed radiographically compared with patients receiving placebo (mean change -0.70 vs. 0.82,...
Source: Telemedicine Business Week (2006-09-13)
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