The USFDA has recently expanded the approval of Centocor, Inc.'s REMICADE® (infliximab) for maintaining clinical remission and mucosal healing in patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response to conventional therapy.
The said approval was primarily based on a one-year data from the ACT 1 randomized, double-blind, multicenter, placebo-controlled clinical trial, which found that patients receiving REMICADE® were more than twice as likely to be in clinical remission at week 54 compared to placebo (35% vs. 17%, respectively).
Furthermore, patients receiving REMICADE were nearly three times as likely as patients in the placebo group to maintain clinical remission from their symptoms after one year (i.e., be in clinical remission at week 8, week 30, and week 54; 20 percent versus 7 percent, respectively).
In addition, 45 percent of REMICADE patients had mucosal healing at week 54 compared to 18 percent of patients in the placebo group.
REMICADE®'s efficacy in the treatment of inflammatory bowel disease (IBD) is already well established: first approved in the United States for the treatment of Crohn's disease (CD) in 1998 and later approved for the treatment of UC in September 2005.
This new expanded addition to REMICADE®'s indication for maintenance therapy in UC, just made REMICADE® the only biologic indicated for inducing and maintaining clinical remission of both types of IBD.
Find more details from Centocor's press release.
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