Navigation Links
Remicade(R) Get Approval for First and Only Biologic Treatment for Pediatric Crohn's Disease

HORSHAM, Pa. and KENILWORTH, N.J., Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP) today announced that the European Commission has approved a new indication for REMICADE(R) (infliximab) allowing for the treatment of severe, active Crohn's disease (CD) in pediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy, or who are intolerant to, or have contraindications for, such therapies.

REMICADE has been studied only in combination with conventional immunosuppressive therapy. This approval follows a positive opinion granted in March by the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency (EMEA).

"Crohn's disease significantly impacts the quality of life of children suffering from this condition," said Salvatore Cucchiara, M.D., Department of Pediatrics, Gastrointestinal Motility and Endoscopy Unit, University of Naples. "Infliximab provides physicians with a new treatment option that addresses the unique aspects of this difficult-to-treat disease in the pediatric population."

REMICADE is the first and only biologic therapy approved in the EU for the treatment of pediatric CD, a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain, weight loss and in some patients, delayed development and stunted growth.

"This approval recognizes the unique value of REMICADE as it is the first and only biologic therapy available to children suffering with Crohn's disease in Europe, who previously had limited therapy options," said Robert J. Spiegel, M.D., chief medical officer, Schering-Plough Research Institute.

In May 2006, the United States Food and Drug Administration (FDA) approved REMICADE for pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy. REMICADE was first approved in the U.S. for adult Crohn's disease in 1998 and later for adult ulcerative colitis in 2005.

The safety and efficacy of REMICADE across all indications have been well established in clinical trials over the past 14 years and through commercial experience with nearly 925,000 patients treated worldwide across all indications.

The label extension will permit physicians to administer a 5 mg/kg intravenous infusion of REMICADE over a 2-hour period followed by additional 5 mg/kg infusion doses at two and six weeks after the first infusion, then every eight weeks thereafter.

Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient. Available data do not support further REMICADE treatment in pediatric patients not responding within the first 10 weeks of treatment.


'"/>




Related medicine news :

1. Approval for DNA test to detect cystic fibrosis
2. Vaccine For Cervical Cancer Awaits Approval
3. WHO Gives Its Approval For Bird Flu Test Kit
4. FDA Gives Its Approval For Inhaler
5. RotaTeq Gets US Approval
6. Better Communication With FDA Could Speed Up Approval Of New Drugs
7. Nerve Stimulator for Depression Though Not Effective Was Given Approval
8. Ranbaxy Gets USFDA Approval For Doxycycline Tablets
9. Global Education Net Pvt Medical College Gets MCI Approval
10. Approval of Drugs for the Treatment of Late-Stage Cancer
11. Lupin Gets USFDA Approval For Quinapril Tablets
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/25/2016)... ... , ... Austin residents seeking Mohs surgery services, can now turn to Dr. ... Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include ... in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has ... he has implemented orthobiologic procedures as a method for treating his patients. The ... first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle ... chronic pain and the benefits of holistic treatments, Serenity Recovery Center of ... Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions today ... cultivation and processing operations at its production facility, and opened its first two ... the manufacturer of a complete system of proactive air and surface purification solutions ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Research and Markets has ... 2015-2025: Applications, Technologies, Forecasts" report to their ... Electronics, Smart Skin, Structural Health Monitoring, Composite Smart ... electronics involves electronic and/or electrical components and circuits ... structures such as vehicle bodies or conformally placed ...
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, ... -based mobile pulmonary function testing company, is now able to perform ... developed by ndd Medical Technologies , Inc. ... in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL ... can get any needed testing done in the comfort of her ...
(Date:6/24/2016)... 2016   Pulmatrix, Inc ., (NASDAQ: ... drugs, announced today that it was added to the ... its comprehensive set of U.S. and global equity indexes ... important milestone for Pulmatrix," said Chief Executive Officer ... our progress in developing drugs for crucial unmet medical ...
Breaking Medicine Technology: