Navigation Links
REMICADE® Receives FDA Approval as First Biologic Treatment for Pediatric Ulcerative Colitis
Date:9/23/2011

ients had failed to respond to or tolerate treatment with 6-mercaptopurine, azathioprine, corticosteroids and/or 5-aminosalicylates.  Patients received REMICADE® 5 mg/kg at weeks 0, 2, and 6.  The primary endpoint, clinical response at week 8, was defined as a decrease from baseline in the Mayo score of at least 30 percent and at least 3 points, with a decrease in rectal bleeding subscore of at least 1 or a rectal bleeding subscore of 0/1.  Patients who achieved clinical response at week 8 were randomized to receive REMICADE® 5 mg/kg every 8 weeks through week 46 or every 12 weeks through week 42.  Non-responders were discontinued from study agent.  

Safety data from the pediatric UC trial were consistent with current REMICADE® labeling.  No new safety concerns emerged in evaluating REMICADE® in the treatment of a pediatric UC population.

For more information regarding the safety profile for REMICADE®, please see "Important Safety Information" below.  

About Ulcerative Colitis

Ulcerative colitis (UC) is a chronic IBD of the colon.  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 debilitating symptoms of IBD.(1)  

About REMICADE®

REMICADE® was the first anti-TNF-alpha treatment approved in the United States in August 1998 and the first TNF inhibitor to be approved in three different therapeutic areas: gastroenterology, rheumatology and dermatology.  REMICADE® has demonstrated broad clinical utility with indications in Crohn's disease, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, ulcerative colitis (UC), pediatric Crohn's disease, psoriasis, and pediatric UC.  The safety and efficacy of REMICADE® have been well established in clinical trials over
'/>"/>

SOURCE Janssen Biotech, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. New Anti-TNF Study Shows Patients With Rheumatoid Arthritis Receiving REMICADE® After Inadequate Response to Enbrel® or Humira® Demonstrate Marked Clinical Improvement
2. Centocor Ortho Biotech Inc. Submits Application to FDA Seeking REMICADE® Pediatric Ulcerative Colitis Indication
3. FDA Advisory Committee Recommends Approval of REMICADE® for Treatment of Pediatric Ulcerative Colitis
4. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
5. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
6. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
7. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
8. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
9. CryoCor Receives FDA Approval for Right Atrial Flutter
10. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
11. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... Calif. , Aug. 27, 2015 DURECT ... is scheduled to present at three upcoming healthcare conferences.  ... President and CEO, will present at the Rodman & ... a.m. Eastern time. The conference is being held at ... City . A live audio webcast of the ...
(Date:8/27/2015)... 2015 According to a new market research ... Universal, Standing, Bariatric ), Material (Nylon, Padded, Canvas), Usage Type (Disposable, ... by MarketsandMarkets, the Medical Lifting Sling Market is poised to reach ... at a CAGR of 11.4 % from 2015 to 2020. ... rket data T ables and 65 ...
(Date:8/27/2015)... N.J. , Aug. 27, 2015   Women Grow , ... cannabis industry, is partnering with the Cannabis World Congress ... to produce 15 business-focused educational sessions. CWCBExpo in ... Los Angeles Convention Center in ... event on the West Coast for the marijuana industry. ...
Breaking Medicine Technology:DURECT to Participate in Upcoming Healthcare Conferences 2Medical Lifting Sling Market Worth USD 706.0 Million by 2020 2Medical Lifting Sling Market Worth USD 706.0 Million by 2020 3Medical Lifting Sling Market Worth USD 706.0 Million by 2020 4Cannabis World Congress in Los Angeles Boasts Women Grow Sponsored Education 2Cannabis World Congress in Los Angeles Boasts Women Grow Sponsored Education 3Cannabis World Congress in Los Angeles Boasts Women Grow Sponsored Education 4
... CLL Survival Analysis Selected for ASH Press Briefing, ... (Nasdaq: GNTA ) announced that several abstracts ... at the annual meeting of the,American Society of ... Programs involving Genasense(R) (oblimersen sodium) Injection,Genta,s lead anticancer ...
... Trial Published in Online Edition ... of the Journal ... and improved fatigue, overall,quality of life and anemia in a diverse ... (PNH), according,to an analysis of the Phase III SHEPHERD study published ...
Cached Medicine Technology:Genta Clinical Programs Featured at American Society of Hematology Meeting 2Genta Clinical Programs Featured at American Society of Hematology Meeting 3Genta Clinical Programs Featured at American Society of Hematology Meeting 4Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients 2Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients 3Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients 4Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients 5Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients 6Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients 7
(Date:8/28/2015)... TX (PRWEB) , ... August 28, 2015 , ... For ... Center is taking part with their subsidiary USPI Tenet Health. , The American Heart ... fight heart disease and stroke. They believe that together, a difference can be made. ...
(Date:8/28/2015)... Hanover, MA (PRWEB) , ... August 28, 2015 , ... ... benefitting the renowned Brain Aneurysm Foundation has added yet another accolade to its ... Chicago, Rahm Emanuel. , “With the help of the medical community and ...
(Date:8/28/2015)... ... August 28, 2015 , ... ... high grade protein with zero fat, carbs, sugar, gluten, lactose or caffeine in ... finalist for the 2015 SupplySide CPG Editor’s Choice Awards. , Five consumer packaged ...
(Date:8/28/2015)... Boynton Beach, FL. (PRWEB) , ... August 28, ... ... creating problems for businesses nationwide. Addictions specialist, Dr. James Strawbridge, gives a new ... Strawbridge believes that it should begin with the employer and employees getting together ...
(Date:8/28/2015)... ... August 28, 2015 , ... CARF ... its adolescent residential, counseling, day treatment and intensive family based services. , By ... for quality and its pursuit of excellence. As a nonprofit charity for more ...
Breaking Medicine News(10 mins):Health News:North Central Surgical Center’s Subsidiary Participates in Walk 2Health News:Chicago Mayor Pens Official Support of Annual Survivor in the City Event Benefitting Brain Aneurysm Foundation 2Health News:Chicago Mayor Pens Official Support of Annual Survivor in the City Event Benefitting Brain Aneurysm Foundation 3Health News:Pocket Protein™ Named 2015 CPG Editor’s Choice Award Finalist by Informa’s SupplySide 2Health News:Pocket Protein™ Named 2015 CPG Editor’s Choice Award Finalist by Informa’s SupplySide 3Health News:West Ridge Academy Awarded CARF Three-Year Accrediation 2
... learn whether protein supplements and cycling during treatments can ... function, thanks to a $2.1 million grant from the ... failure face many health problems. They are at high ... and they also develop a peculiar condition called vascular ...
... a model of stroke A team of researchers, led ... identified a way to preserve nerve cells in a rat model ... of oxygen to part of the brain as a result of ... leads to nerve cell death, although the exact mechanisms underlying ischemic ...
... shoulder muscles in elderly patients is often discouraged because of ... Rush University Medical Center has shown that minimally invasive, or ... study has just been published online in Arthroscopy: ... appear in the October issue. "In people over the ...
... study of Ewing,s sarcoma that screened hundreds of genes based ... anti-cancer drug targets, according to a scientific paper by the ... journal Molecular Cancer . Ewing,s sarcomas are rare, ... bones of teenagers. They represent nearly 3 percent of all ...
... the probability of dying in road accidents on the basis ... Their conclusions are clear reducing the time between an ... from 25 to 15 minutes would cut the risk of ... until the emergency medical services arrive is 25 minutes in ...
... Faith based schools are on the rise in ... values at odds with legislation on equality? Research that ... Leadership published by SAGE shows what happens when school ... consequences for gay students and staff. The UK ...
Cached Medicine News:Health News:Will extra protein and exercise help dialysis patients? U of I profs get $2.1 million to find out 2Health News:Will extra protein and exercise help dialysis patients? U of I profs get $2.1 million to find out 3Health News:JCI online early table of contents: Sept. 1, 2010 2Health News:JCI online early table of contents: Sept. 1, 2010 3Health News:JCI online early table of contents: Sept. 1, 2010 4Health News:JCI online early table of contents: Sept. 1, 2010 5Health News:JCI online early table of contents: Sept. 1, 2010 6Health News:Surgery to repair torn shoulder muscles in the elderly can reduce pain and improve function 2Health News:TGen finds therapeutic targets for rare cancer in children 2Health News:10 minutes could prevent one-third of road deaths 2Health News:Keeping faith -- schools must balance ethos with equality 2
TeleRehab Advantage is a monitoring system that automates the generation of outcomes data. Patient information and session information is automatically transferred from the monitoring program to Outc...
... Clearly, the ISI Lexan ... versatile surgical table for lower ... orthopaedic, head and neck, and ... optional traction package gives you ...
MagaCell-Streptavidin is a streptavidin coupled to magnetizable cellulose/iron oxide particles...
Streptavidin A-Beads are polydisperse 1.8 m paramagnetic particles covalently coupled with streptavidin. The paramagnetic particles remain in solution over extended periods of time. Mixing is require...
Medicine Products: