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

174; 5 mg/kg induced clinical response in 73 percent of patients at week 8 and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.  

"Today's approval of REMICADE® is significant for children and their families who are affected by this devastating disease and are seeking an effective treatment option," said Rob Bazemore, President, Janssen Biotech, Inc.  "We are proud of our heritage in the continued pursuit of expanding treatment options for patients living with immune-mediated inflammatory diseases like IBD."

REMICADE® was designated orphan drug status by the FDA on November 12, 2003, and the supplemental Biologics License Applications (sBLA) for pediatric UC received priority review following its submission to the FDA in December 2010. The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) recommended the approval of REMICADE® in pediatric patients with UC.

On September 1, 2011, Janssen Inc. announced Health Canada approved REMICADE® for the treatment of pediatric patients (age six to 17 years) with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

About the Study

The Phase 3 randomized, multicenter, open-label trial was designed to evaluate the efficacy of a 3-dose REMICADE® regimen in inducing clinical response in pediatric patients with moderately to severely active UC and to evaluate the safety of REMICADE® during induction and maintenance treatment.  A total of 60 patients, aged 6-17, with a median disease duration of 1.4 years were included in the study.  Patients had a median Mayo score of 8.0, and median Pediatric Ulcerative Colitis Activity Index (PUCAI) score of 55.  All pat
'/>"/>

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:8/28/2014)... Aug. 28, 2014 /PRNewswire-iReach/ -- CountryFocus: Healthcare, Regulatory ... (Photo - http://photos.prnewswire.com/prnh/20140828/140879 ) ... Regulatory and Reimbursement Landscape Poland " an essential ... in the healthcare market and provides insights into ... Most importantly, the report provides valuable insights into ...
(Date:8/28/2014)... , Aug. 28, 2014  Decision Resources Group finds that ... at around $7.7 billion by 2023 in the ... Germany , Italy , ... and Japan . The biosimilar erosion ... be balanced out by the launch of Eli Lilly,s Cyramza, ...
(Date:8/28/2014)... , Aug. 28, 2014   Edison Nation ... announced a worldwide search for product ideas to ... population.  Promising ideas uncovered through the 6-month search ... medical device manufacturers and healthcare retailers with whom ... lives of individuals age 65 and older. ...
Breaking Medicine Technology:Poland & Turkey Pharmaceutical Market worth $15 billion & $21.5 billion Respectively by 2020 2Poland & Turkey Pharmaceutical Market worth $15 billion & $21.5 billion Respectively by 2020 3Poland & Turkey Pharmaceutical Market worth $15 billion & $21.5 billion Respectively by 2020 4Poland & Turkey Pharmaceutical Market worth $15 billion & $21.5 billion Respectively by 2020 5The Colorectal Cancer Market Will Remain Steady at $7.7 Billion by 2023, With Biosimilar Erosion Of Key Agents Being Balanced Out By the Launch Of Premium-Priced Therapies 2Edison Nation Medical Launches Open Innovation Search to Uncover Innovative Senior Care Products 2Edison Nation Medical Launches Open Innovation Search to Uncover Innovative Senior Care Products 3
(Date:8/29/2014)... Sansego is an online ... online community, and a range of personalized coaching services. ... way to professional athletes. Crowie has brought together a ... him throughout the majority of his triathlon career. Now, ... triathlon public. , Sansego provides the following:, ...
(Date:8/29/2014)... (PRWEB) August 29, 2014 RBS Reputation Management ... Scam Book. The service is to help those individuals ... against them on Scam Book. The service would push down ... make Scam Book complaints fully invisible on Google. , ... , On being asked how company can provide guarantee ...
(Date:8/29/2014)... Pittsburgh, PA (PRWEB) August 29, 2014 "After ... people who don’t stand very often, I decided that there ... longer periods during the day," said a concerned inventor from ... can’t stand for long periods. It builds endurance and keeps ... promote better health. Easy to use and producible in design ...
(Date:8/29/2014)... Only a handful of CPR and basic life ... which are consistent with recent health guidelines, according ... Medicine Australasia , the journal for the Australasian ... recognition and treatment of sudden cardiac arrest are ... of Turkish emergency medicine specialists put together the ...
(Date:8/29/2014)... Miami, Florida (PRWEB) August 29, 2014 ... is pleased to introduce its new Fresh Vegetarian meal ... nutritionally balanced fresh meals, the new menu is designed ... enhance their vegetarian lifestyle. , Responding to ... estimated to be a multi-billion dollar market (Forbes) with ...
Breaking Medicine News(10 mins):Health News:5 x World Champion Triathlete, Craig “Crowie” Alexander, Launches Online Triathlon Coaching Company – Sansego 2Health News:5 x World Champion Triathlete, Craig “Crowie” Alexander, Launches Online Triathlon Coaching Company – Sansego 3Health News:RBS Reputation Management Announces a New Online Reputation Management Service 2Health News:The Fresh Diet America's #1 At-Home Meal Delivery Company, Debuts Fresh Vegetarian Meal Plan Offering All-Natural Ingredients 2Health News:The Fresh Diet America's #1 At-Home Meal Delivery Company, Debuts Fresh Vegetarian Meal Plan Offering All-Natural Ingredients 3
... by the placenta may damage blood vessels in women ... pregnancy linked to life-threatening increases in high blood pressure ... recognized that substances called "microparticles" released by the placenta ... Medicine, led by Seth Guller, sought to detect whether ...
... at the University of British Columbia have discovered new ... cancer. // ,The research conducted by UBC stem ... podocalyxin – which the researchers had previously shown to ... the shape and adhesive quality of tumour cells, affecting ...
... with facts and figures has shown the dangerous increase in ... years//. The number of children below five years of age, ... fold between 1985 and 2004. ,Type 1 diabetes ... childhood as opposed to Type 2 diabetes, which develops much ...
... Space Administration (NASA) has revealed that the sunscreen of ... 1990s. ,Aerosols are tiny particles suspended in ... storms, forest and grassland fires, living vegetation, and sea ... the Earth's surface immediately below them. ...
... out strongly against the use of sunbeds or tanning beds, ... to the Working Group on artificial UV light and skin ... persons who use these tanning beds in order to avoid ... higher risks of developing melanoma, the most dreaded skin cancer. ...
... organizations in Maine criticized the anti-fluoride campaigns made by a ... believe the false information and alter their water treatment policies. ... for Disease Control had confirmed in a news conference that ... in fighting tooth decay. ,This announcement has ...
Cached Medicine News:Health News:New Non-toxic Therapies for Breast, Ovarian Cancers 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 ...
... 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 ...
... 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 ...
... 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: