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:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Lori R. ... a member of ElderCounsel, a national organization of elder law and special needs planning ... laws and rules. It also provides a forum to network with elder law attorneys ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading ... to advocate for action towards gender equality at their inaugural Summit in New York ... globe, and reached a social audience of over 3 million. To watch the Mobilize ...
(Date:10/13/2017)... Fairfax, VA (PRWEB) , ... October 13, 2017 ... ... provider of DevOps and Agile Software Development, has been awarded a contract by ... (EATS) Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile ...
(Date:10/12/2017)... CA (PRWEB) , ... October 12, 2017 , ... ... Cheng, are now treating sleep apnea using cutting-edge Oventus O2Vent technology. ... a serious sleep disorder characterized by frequent cessation in breathing. Oral appliances can ...
(Date:10/12/2017)... ... 12, 2017 , ... The American College of Medical Informatics (ACMI) will present ... the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium ... Collen, a pioneer in the field of medical informatics, this prestigious award is presented ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... AMSTERDAM , Sept. 25, 2017   ... Trial Master File solutions, today—from the IQPC Trial ... Amsterdam , NL)—announced that EastHORN Clinical Services ... its clinical programs and TMF management. EastHORN, a ... Montrium,s eTMF platform to increase transparency to enable ...
(Date:9/22/2017)... 22, 2017  As the latest Obamacare repeal effort ... Cassidy (R-LA) and Lindsey Graham (R-SC) ... medical device industry is in an odd place.  The ... 2.3% excise tax on medical device sales passed along ... covered patients, increased visits and hospital customers with the ...
(Date:9/19/2017)... Ky. , Sept. 19, 2017   ZirMed Inc ... predictive analytics, today announced that it has been ranked #1 ... Black Book™ Rankings 2017 User Survey. ZirMed was ... solution for large hospitals and medical centers over 200 beds ... Black Book,s healthcare technology user survey history. ...
Breaking Medicine Technology: