Navigation Links
FDA Approves New Multiple Sclerosis Drug

THURSDAY, March 28 (HealthDay News) -- A new drug called Tecfidera has been approved to treat adults with relapsing forms of multiple sclerosis, the U.S. Food and Drug Administration said Wednesday.

The approval is based on the results of two clinical trials showing that patients who took Tecfidera (dimethyl fumarate) capsules had fewer MS relapses than those who took an inactive placebo. One of the trials also showed that a worsening of MS-related disability occurred less often in patients who took the drug than in those who took the placebo.

"Tecfidera will be a welcome addition to the growing list of agents that alter the course of multiple sclerosis," said one expert, Dr. Fred Lublin, director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai Medical Center in New York City.

"Based on the clinical trial data available, this new agent has very impressive efficacy data and a good safety profile," he added.

The FDA said that Tecfidera may lower levels of white blood cells, which help protect the body from infection. Lower levels of white blood cells may increase the risk of infection, but no significant increase in infections occurred in patients taking the drug.

Before starting treatment with Tecfidera, and each year after, doctors should check patients' white blood cell counts, the FDA advised.

Flushing (warmth and redness), nausea, vomiting and diarrhea were the most common side effects in patients taking the drug, especially at the start of treatment with Tecfidera, which is made by Biogen Idec in Massachusetts.

"No drug provides a cure for multiple sclerosis, so it is important to have a variety of treatment options available for patients," Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

"Multiple sclerosis can impair movement, sensation and thinking, and have a profound impact on a person's quality of life," he added.

MS is an autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body, resulting in problems such as muscle weakness and difficulty with coordination and balance.

For most MS patients, periods of worsening disability (relapses) are initially followed by recovery periods (remissions). Over time, these recovery periods may be incomplete, resulting in a progressive increase in disability.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about multiple sclerosis.

-- Robert Preidt

SOURCES: Fred Lublin, M.D., director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai Medical Center, New York City; U.S. Food and Drug Administration, news release, March 27, 2013

Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Approves Generic Versions of Plavix
2. FDA Approves Combo Shot for Meningitis, Hib in Kids
3. FDA Approves SonixGPS Needle Guidance Technology for Vascular Access Procedures
4. FDA Approves First New Weight-Loss Drug in More Than a Decade
5. FDA Approves 1st Pill to Help Prevent HIV Infection
6. FDA Approves 2nd New Weight-Loss Drug
7. FDA Approves Flu Vaccine for Coming Season
8. FDA Approves New Once-a-Day HIV Pill
9. FDA Approves New Type of Flu Vaccine
10. Environmental Protection Agency Approves MOMS by OdorXit as a Disinfectant
11. FDA Approves 1st Skin Patch to Combat Migraines
Post Your Comments:
Related Image:
FDA Approves New Multiple Sclerosis Drug
(Date:6/27/2016)... Viejo, California (PRWEB) , ... June 27, 2016 , ... ... are fully customizable inside of Final Cut Pro X," said Christina Austin - CEO ... another unique style. Final Cut Pro X users can now reveal the ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... industry today announced its strategic partnership with Connance, a healthcare industry leader ... two companies’ proven, proprietary technology combine to provide health systems, hospitals and ...
(Date:6/27/2016)... ... , ... recently awarded their highest five-star rating to Best Buy Eyeglasses, ... the United States and Canada wear eyeglasses. Once considered to be a purely functional ... a fashion statement. Even celebrities use glasses as a way of creating an iconic ...
(Date:6/26/2016)... ... 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment ... Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This ... of the world’s leading providers of cereal and other breakfast foods. Its residents often ...
(Date:6/26/2016)... ... ... PawPaws brand pet supplements owned by Whole Health Supply is ... of felines. The formula is all-natural and is made from Chinese herbs that have ... Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root Extract ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Research ... Pharma News Issue 52" report to their offering. ... in influenza treatment creates a favourable commercial environment for MedImmune ... growing patient base that will serve to drive considerable growth ... vaccine would serve to cap sales considerably, but development is ...
(Date:6/23/2016)... and INDIANAPOLIS , June ... receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship is any ... scholarship winners, announced today online at ... type 1 diabetes stand in the way of academic ... supported the Foundation,s scholarship program since 2012, and continues ...
(Date:6/23/2016)... 23, 2016  Guerbet announced today that it has ... Horizon Award . One of 12 suppliers ... for its support of Premier members through exceptional local ... and commitment to lower costs. ... of our outstanding customer service from Premier," says ...
Breaking Medicine Technology: