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:
*Name:
*Comment:
*Email:


(Date:2/11/2016)... , ... February 11, 2016 , ... ... J.R. Garrett Esq. as General Counsel. Garrett will focus on contract negotiations, corporate ... audits, privacy and security law, and best practices in data breaches for the ...
(Date:2/11/2016)... ... February 11, 2016 , ... AccuVein Inc. ... Infusion Therapy Standards of Practice, to include vascular visualization as a standard practice. ... 85% share of the market, facilitates adherence to this standard with its easy ...
(Date:2/11/2016)... ... ... The annual list showcases the 20 Most Promising SharePoint Solution Providers in 2015. ... to the SharePoint ecosystem. A panel of experts and members of CIOReview’s editorial board ... promote technology entrepreneurship. , The survey was made at the end of the ...
(Date:2/11/2016)... , ... February 11, 2016 , ... ... dynamometers and ergoFET force gauges used in physical therapy, occupational therapy and sports ... sensor for resistance cord exercise and therapy, introduces its new microFET Digital Pinch ...
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... ... coverage results in significantly higher rates of several common cancer screenings, especially among ... in better outcomes and survival rates. , The study,“What Does Medicaid Expansion ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... 2016  M3 Biotechnology Inc., spurred by a major "team investment" by Bruce Montgomery , ... an oversubscribed Series A-Round, according to CEO Leen Kawas , PhD. ... ... ... Kawas said the ...
(Date:2/11/2016)... Calif. , Feb. 11, 2016  AcelRx Pharmaceuticals, ... podium presentation will be made at the 38th annual ... and Wound Care Symposium, which is being held February ... international conference covers the latest advancements in wound healing, ... the American Burn Association, Australian-New Zealand Burns Association, Academy ...
(Date:2/11/2016)... TEL AVIV, Israel , Feb. 11, 2016  Galmed ... clinical-stage biopharmaceutical company focused on the development of a ... announced today that its Chief Medical Officer, Dr. ... retiring from Galmed as Chief Medical Officer and from ... 2016 due to her reaching retirement age. ...
Breaking Medicine Technology: