XML Feed for RxPG News   Add RxPG News Headlines to My Yahoo!   Javascript Syndication for RxPG News

Research Health World General
 Latest Research
  Anti-Clotting Drugs
  Anti Cancer Drugs
  Fatty Acids
 Infectious Diseases
 Respiratory Medicine
 Public Health
 Clinical Trials
 Medical News
 Awards & Prizes
 Special Topics
 Odd Medical News
 World News

Last Updated: Aug 19th, 2006 - 22:18:38

Pharmacology Channel
subscribe to Pharmacology newsletter

Latest Research : Pharmacology

   DISCUSS   |   EMAIL   |   PRINT
FDA Approves Remicade for Crohn’s Disease in Children
May 20, 2006, 02:57, Reviewed by: Dr. Priya Saxena

"Remicade is not a cure, but it provides a much-needed option for reducing the symptoms and inducing and maintaining disease remission in children who have no other safe and effective therapy."

The Food and Drug Administration today approved Remicade (infliximab) to treat children with active Crohn's disease, a chronic, inflammatory condition of the bowel that can be severely debilitating. Remicade is a genetically engineered monoclonal antibody, which reduces inflammation (swelling/redness) by blocking the action of tumor necrosis factor-alpha (TNF-α), that was initially approved in 1998 to treat Crohn's disease in adults.

Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, noted that there have been no satisfactory treatments for children with Crohn's disease who have moderate to severe disease activity despite traditional or conventional therapies. Crohn's disease can cause diarrhea, cramping, abdominal pain, gastrointestinal bleeding, and in some cases creates abnormal connections (fistulas) leading from the intestine to the skin.

"Remicade is not a cure, but it provides a much-needed option for reducing the symptoms and inducing and maintaining disease remission in children who have no other safe and effective therapy," he said. "We believe that the potential benefits of this product outweigh the risks that are known and have been carefully evaluated."

The safety and effectiveness of Remicade in pediatric Crohn's disease were assessed in a randomized study in 112 children who were 6 to 17 years old with moderately to severely active Crohn's disease who had an inadequate response to conventional therapies. The proportion of these patients who achieved clinical response compared favorably with the proportion of adults in an earlier Remicade study in adult Crohn's disease, and the pediatric trial's results showed no new safety concerns not already expressed in the product's current label.

In general, the safety profile for Remicade in the pediatric trial was similar to the data that was presented at an FDA Arthritis Advisory Committee meeting in March 2003, and that dealt with the extent to which anti-TNF therapies may increase the risk of serious infections and malignancies, such as sepsis and pneumonia in certain patients.

These risks, which are described in a study in the May 17 issue of the Journal of the American Medical Association, are included in the current labels for all approved TNF-alpha blocking agents, including Remicade.

More recently, the FDA has received rare post-marketing reports of an aggressive and often fatal type of T-cell lymphoma (hepatosplenic T-cell lymphoma) in adolescent and young adult patients with the Crohn's disease. In most, but not all cases, these patients were treated with standard immunosuppressive therapies (azathioprine or 6-mercaptopurine) in combination with Remicade. The FDA is working with the manufacturer to address this risk by updating the Warnings sections of the Remicade label.

FDA continues to actively and carefully monitor the safety experience with Remicade and similar therapies in an effort to maximize their very real benefits yet limit, to the degree possible, the potential for very serious toxicities.




Subscribe to Pharmacology Newsletter
E-mail Address:


Related Pharmacology News

Phase Ib Trial Is Evaluating Bavituximab Administered With Common Chemotherapy Regimens
Two-component lantibiotic with therapeutic potential discovered
Prescription pain medication abuse on rise
Antibiotic inhibits cancer gene activity
NRTIs limits the atherogenic side effect of the protease inhibitors
Cyclin-dependent kinase inhibitors: The latest anti-inflammatory
FDA requested to promptly approve 17-P to prevent premature birth
Rapamycin shown to inhibit angiogenesis
Tigecycline, worlds first glycylcycline expanded broad-spectrum antibiotic, launched in UK
Ibuprofen - worsening cognitive function

For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page


© Copyright 2004 onwards by RxPG Medical Solutions Private Limited
Contact Us