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:3/27/2017)... Fla. (PRWEB) , ... March 27, 2017 , ... ... overdose deaths soared 167%,(1) with opioids alone responsible for over 33,000 of the ... McCarty has sponsored Assembly Bill (AB) 1512, which proposes a tax on prescription ...
(Date:3/25/2017)... ... ... Norland at Swissray is pleased to announce the release of the ELITE DXA, ... has an active scan window, which is more than double that of existing bone densitometers. ... could not undergo an accurate total body bone density or body composition study. ...
(Date:3/24/2017)... Greenville, SC (PRWEB) , ... March 24, 2017 , ... ... , is excited to announce the opening of a Greenville, South Carolina ... center for digital progress in Greenville. , “We’ve been working with South Carolina clients ...
(Date:3/24/2017)... , ... March 24, 2017 , ... ... planning, and related services to families and business owners across eastern Michigan, is ... feeding regional families struggling with financial difficulties. , The Oxford/Orion FISH Food Pantry ...
(Date:3/24/2017)... CA (PRWEB) , ... March 24, 2017 , ... ... on two panels at the Advanced ERISA Benefit Claims Litigation seminar in Chicago, ... Creating the Administrative Record, The majority of cases litigated under ERISA involve claims ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... Research and Markets has announced the addition of the "Global Wound ... report to their offering. ... The global wound care market was worth $24,482.9 million in 2015 and ... Among the various wound care products type, the advanced wound ... 2015. Among the various applications, surgical wound segment held the largest share ...
(Date:3/24/2017)... 2017   The Accreditation Council for Medical ... in the pharmaceutical industry has appointed Dr. ... newly formed scientific advisory board. Dr. Chin will ... first ever medical affairs think tank within the ... the ACMA, please visit  www.medicalaffairsspecialist.org .  Connect ...
(Date:3/24/2017)... , March 24, 2017 FinancialBuzz.com News Commentary ... Medical cannabis products around ... Research, Inc., projects that the global medical cannabis market will reach a ... is a major market for the new growing industry. By the ... to legally buy and sell medical cannabis. More conservative states like ...
Breaking Medicine Technology: