Navigation Links
FDA Accords Priority Review For Pediatric Crohn's Disease Drug

The U.S. Food and Drug Administration (FDA) has decided to accord a priority review for the drug REMICADE (R) (infliximab) to be used in the treatment of pediatric// Crohn's disease, the drug's manufacturer Centocor, Inc. announced today. Crohn's disease affects the gastrointestinal tract and causes diarrhea, fever, abdominal pain and weight loss. As of now there is no drug to treat children who develop this condition. Centocor had filed a supplemental Biologics License Application (sBLA), which was accepted by the FDA.

The filing is based primarily on Phase 3 study results showing the unprecedented efficacy of REMICADE in the treatment of children with moderately to severely active Crohn's disease. In the REACH (a Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF Monoclonal Antibody REMICADE in Pediatric Subjects with Moderate to Severe Crohn's Disease) trial, nearly 90 percent (88.4 percent) of pediatric patients with moderately to severely active Crohn's disease who had an inadequate response to conventional therapy achieved clinical response at week 10 when treated with REMICADE. Nearly two-thirds (63.5 percent) of the patients who were randomized to treatment with REMICADE every 8 weeks were in clinical response at one year. Additionally, more than half of the patients treated with REMICADE every 8 weeks were in clinical remission at the end of one year.

"We are extremely pleased by the results of the REACH trial and by the FDA's decision to accept the application with a Priority Review," said Jerome A. Boscia, MD, Senior Vice President, Clinical Research and Development, Centocor, Inc. "REMICADE, if approved for the treatment of pediatric Crohn's disease, would represent a major advancement for children with this serious condition. We look forward to working closely with the FDA as it reviews these data for approval."

Priority Review is granted by the FDA to products that are considered to be a potential therapeutic advance over current therapies. Acceptance of the sBLA filing does not mean that a license has been issued for this indication nor does it represent any evaluation of the adequacy of the data submitted in the sBLA. REMICADE was FDA-approved in 1998 as the first biologic treatment for adults with moderate to severe Crohn's disease. In September 2005, REMICADE also became the first approved biologic treatment for moderate to severe ulcerative colitis (UC), making it the only biologic indicated for the treatment of both types of inflammatory bowel disease (IBD) in adults. Contact: Michael Parks 215-983-8000 Centocor, Inc. Source: Eurekalert

Related medicine news :

1. British MPs Say Prostate Cancer Receives Low Priority in the NHS
2. Funds Pumped In To Reduce Waiting List of Priority Patients
3. Children Health Care To Be Given Priority
4. Hypertension Not Given Priority during Treatment
5. Healthcare And Education Top Most Priority Of The Govt: Nitish
6. Global Health Issues To Take Priority In The Current G8 Summit In Russia
7. Consistent National Standards For Assessment Of Overseas Trained Doctors A Priority
8. Women and Children Issues Should Get Priority in India
9. WHO Urges Higher Priority for Neglected Diseases
10. COAG Must Make Combating Severe Allergies A National Priority
11. Priority Needs to Be Given to Maternal Health in Afghanistan
Post Your Comments:

(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas ... , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct ...
(Date:6/24/2016)... ... 2016 , ... People across the U.S. are sharpening their pencils and honing ... contest in which patients and their families pay tribute to a genetic counselor by ... Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... The Grove Investment Group (TGIG), has initiated cultivation and processing operations at its ... Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of a complete system ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) ... held on June 20th at the Woodmont Country Club at 1201 Rockville Pike, ... organization dedicated to helping service members that have been wounded in battle and their ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... --  Pulmatrix, Inc ., (NASDAQ: PULM ), ... today that it was added to the Russell Microcap ... set of U.S. and global equity indexes on June ... for Pulmatrix," said Chief Executive Officer Robert Clarke ... in developing drugs for crucial unmet medical needs, and ...
(Date:6/23/2016)... Calif. , June 23, 2016 Any dentist ... many challenges of the current process. Many of them do ... of the technical difficulties and high laboratory costs involved. And ... to offer it at such a high cost that the ... it. Dr. Parsa Zadeh , founder of ...
(Date:6/23/2016)... June 23, 2016 Capricor ... ), a biotechnology company focused on the discovery, ... that patient enrollment in its ongoing randomized HOPE-Duchenne ... exceeded 50% of its 24-patient target. Capricor expects ... third quarter of 2016, and to report top ...
Breaking Medicine Technology: