« Return to News | Clinical Intelligence

FDA approves REMICADER for pediatric UC

Tuesday, September 27, 2011 12:02 PM

FDA has approved Janssen Biotech’s REMICADER (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.  This marks the 16th approval of REMICADER in the U.S. and the seventh for the anti-tumor necrosis factor (TNF)-alpha in the treatment of inflammatory bowel disease (IBD) spanning adult and pediatric Crohn's disease and adult and pediatric UC.  It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease.  An estimated 150,000 children under age 17 are living with symptoms of IBD.

The approval is supported by evidence from adequate and well-controlled studies of REMICADE in adults with ulcerative colitis plus additional data from a pivotal phase III randomized, multicenter, open-label trial evaluating the efficacy and safety of REMICADER in the treatment of pediatric patients with moderately to severely active UC.  Results from the pediatric UC study showed that treatment with REMICADER 5 mg/kg induced clinical response in 73% of patients at week 8 and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.