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:9/18/2014)... , Sept. 18, 2014  Low T ... committee meeting in Hyattsville, Maryland ... to assess the proper patient population for testosterone ... cardiovascular risk associated with TRT. Examining recent claims from ... found that "available epidemiological studies do not provide ...
(Date:9/18/2014)... , Sept. 18, 2014  Aratana Therapeutics, ... therapeutics company focused on licensing, developing and commercializing ... the full exercise of the underwriters, option to ... connection with the company,s previously announced public offering ... the shares are being offered by Aratana Therapeutics.  ...
(Date:9/18/2014)... 18, 2014 ... has announced the addition of the  "Sugar ... to their offering.       (Logo: ... markets for Sugar Alcohols in Million Pounds ... Confectionery, Pharmaceuticals, Cosmetics, Oral-Care Products, and Others.  ...
Breaking Medicine Technology:Low T Center Endorses The Joint FDA Committee Meeting on Testosterone 2Aratana Therapeutics, Inc. Announces Full Exercise of Underwriters' Option to Purchase Additional Shares 2Sugar Alcohols - Global Strategic Business Report 201 2Sugar Alcohols - Global Strategic Business Report 201 3
... of the premier providers of innovative supplies for continuous ... of its fifth year with a variety of planned ... the high-quality standards and innovation that the home health ... Circadiance has its sights set on being ...
... Jan. 13, 2012 IBM (NYSE: IBM ) ... made from silicon that can aid researchers and ... drug discovery and disease diagnostics. ... Tissue staining is widely used in pathology to ...
Cached Medicine Technology:Circadiance to Launch New Respiratory Supply Products 2MADE IN IBM LABS: New Silicon Probe Assists in Disease Diagnostics and Drug Discovery 2MADE IN IBM LABS: New Silicon Probe Assists in Disease Diagnostics and Drug Discovery 3MADE IN IBM LABS: New Silicon Probe Assists in Disease Diagnostics and Drug Discovery 4
(Date:9/18/2014)... Older people become more physically vulnerable during bereavement, new ... hormones during bereavement changes with age, British researchers say. ... more likely to have weakened immune systems and develop ... and months after loss, we can suffer from reduced ... white blood cell and as such are essential at ...
(Date:9/18/2014)... PRAIRIE, Texas (PRWEB) September 18, 2014 ... for the air medical transport industry, ShandsCair Flight ... Airbus Helicopters Inc . (AHI) at the Air ... , The recently delivered and placed into service ShandsCair ... B4 that will be displayed at AMTC highlight Airbus ...
(Date:9/18/2014)... News) -- Daily supplements of selenium or vitamin E ... age-related cataracts among men, a new study indicates. ... could help prevent cataracts. To investigate this further, William ... School in Boston, and his colleagues examined data from ... The trial was initially designed to study prevention of ...
(Date:9/18/2014)... 18, 2014 Thousands of college and ... their shared fundraising impact on 127 member Children’s ... The first-ever Dance Marathon Day will officially kick off ... to be raised by college and high school students ... generated through Dance Marathon campus programs help provide medical ...
(Date:9/18/2014)... developed a new method to study Ebola virus in ... Conservation Society (WCS)-led research, published today in the journal ... of fecal samples from wild great apes to identify ... This represents a new tool for performing large, population-scale ... virus is studied and improve our understanding of the ...
Breaking Medicine News(10 mins):Health News:Grief Can Weigh on Immune System in Older Folks, Study Says 2Health News:Airbus Helicopters Inc. Features Industry-leading Models at AMTC 2Health News:Airbus Helicopters Inc. Features Industry-leading Models at AMTC 3Health News:Airbus Helicopters Inc. Features Industry-leading Models at AMTC 4Health News:Vitamin E, Selenium Supplements Don't Seem to Prevent Cataracts 2Health News:250 Campuses Usher in School Year of Saving Kids’ Lives During First-Ever “Dance Marathon Day” on Sept. 25 2Health News:Research yields a game changer for improving understanding of Ebola and great apes 2Health News:Research yields a game changer for improving understanding of Ebola and great apes 3
... discovered a new signaling molecule that prevents immune responses ... could lead to the development of new treatments for ... 1 diabetes; and for inflammatory diseases, such as inflammatory ... Jude team discovered that specialized immune lymphocytes called regulatory ...
... Inc. (NYSE: VAR ), a premier supplier of X-ray tubes ... new,PaxScan products at the annual meeting of the Radiological Society of ... 30, 2007., -- The PaxScan 4336R adds a 14 ... of flat panel products. It is specifically designed to ...
... 21 The following release and,statements are attributed ... a nonprofit organization dedicated to raising awareness,and improving ... Americans with liver,disease, issued a statement today expressing ... physician Dr. Harvey Finkelstein made repeated,use of medicine ...
... CHICAGO --- When you meet your boss,s husband, Harvey, at ... later over the onion dip, will you remember his name? ... brain called kalirin-7. , Researchers at ... protein kalirin is critical for helping you learn and remember ...
... Nov. 21 The Advisory Board,Company (Nasdaq: ABCO ... CIBC,World Markets Third Annual Mid & Small Cap ,Best ... York City. Speaking at the conference,on November 28th, 2007 ... Chief Executive Officer, Frank J. Williams, and the Company,s ...
... Komen for the Cure, the,nation,s largest private source ... programs, is accepting applications to award,four-year undergraduate scholarships ... cancer., (Logo: http://www.newscom.com/cgi-bin/prnh/20070122/NYM084LOGO ), The ... costs of,tuition, books, fees and on-campus room and ...
Cached Medicine News:Health News:St. Jude finds molecule that could improve cancer vaccines and therapy for other diseases 2Health News:St. Jude finds molecule that could improve cancer vaccines and therapy for other diseases 3Health News:Varian Medical Systems to Introduce Two New PaxScan(R) Flat-Panel Digital Radiography Products at RSNA This Year 2Health News:Varian Medical Systems to Introduce Two New PaxScan(R) Flat-Panel Digital Radiography Products at RSNA This Year 3Health News:The American Liver Foundation Encourages Heightened Awareness of Hepatitis B and C in Light of Recent Events in the News 2Health News:Why you remember names and ski slopes 2Health News:Susan G. Komen for the Cure Provides Scholarships for Students Who Lost a Parent to Breast Cancer 2
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: