Navigation Links
FDA Approves New Multiple Sclerosis Drug
Date:3/28/2013

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:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves New Multiple Sclerosis Drug
(Date:2/24/2017)... ... ... The Smart Machine Age is here, and it’s disrupting everything. Not only could ... in the United States may be taken over by technology in the next five ... steamrolls over colleagues is drawing to a close. Success will belong to those who ...
(Date:2/24/2017)... ... February 24, 2017 , ... With millions of Americans and ... that we all are aware of our options and are empowered with strength ... the launch of its newest edition of "Vision and Hearing" in USA Today, ...
(Date:2/24/2017)... ... , ... The narrative in “ Signal 8: An Australian Paramedic’s Story ” ... paramedic experiences. Schanssema describes the tragedies he saw, as well as his struggles with ... Schanssema, initially unsure of the career path he wanted to take, found fulfillment in ...
(Date:2/24/2017)... (PRWEB) , ... February 24, 2017 , ... The ... national conference convening academic faculty engaged in or interested in palliative care education and ... will be held in North County San Diego on Sept. 28 and 29, ...
(Date:2/24/2017)... ... ... The International Association of Eating Disorders Professionals (iaedp) announces the 2017 top ... mannequin art competition. Selected from 15 submissions from around the nation, the top five ... annual iaedp Symposium, March 22 – 26 in Las Vegas. , This year, the ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... 2017 Physician General Dr. Rachel Levine ... Jennifer Smith commended South Central EMS today ... using naloxone, a life-saving overdose reversal drug. The recognition ... specialist and overdose survivor who was saved due to ... "A significant part of fighting the opioid epidemic is ...
(Date:2/24/2017)... , Feb. 23, 2017 The U.S. ... the PhenoTest BC Kit, performed on the Pheno ... organisms that cause bloodstream infections and provide information ... respond to (antibiotic sensitivity). The test also reduces ... this important information, which can guide antibiotic treatment ...
(Date:2/24/2017)... , Feb. 23, 2017  Directors from Pharma To Market Pty ... have joined forces, resulting in the founding of Pharma To Market ... Pharma To Market are pleased to announce their expansion into ... Singapore . The company are delighted to appoint ... of the Singapore based entity. Joelle brings ...
Breaking Medicine Technology: