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:10/13/2017)... ... 2017 , ... “The Journey: From the Mountains to the Mission Field”: the ... in the Philippines. “The Journey: From the Mountains to the Mission Field” is the ... She has taught all ages and currently teaches a class of ladies at her ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of ... announced today its plans to open a flagship location in Covington, LA at 401 ... Rooms To Go store next to Office Depot in the Holiday Square shopping center. ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized health ... expanded their existing home health joint venture through an agreement, effective October 1, ... joint venture home health company with Asante, delivering clinically integrated care, for the ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... D.C., for the 49th Congress of the International Society of Paediatric Oncology ... the Center for Cancer and Blood Disorders at Children’s National, and Stephen ...
(Date:10/12/2017)... ... 2017 , ... In the United States, single-family home owners ... New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, and California—the average is $7,000 ... property-tax rates, which contributes to the relatively lower cost of living in places ...
Breaking Medicine News(10 mins):
(Date:9/27/2017)... , Sept. 27, 2017  Commended for their devotion to ... awards. Ranked as number one in the South Florida Business ... in Inc. 5000 yearly list, the national specialty pharmacy has ... Armando Bardisa will soon be honored by SFBJ as ... Set to receive his award in October, ...
(Date:9/25/2017)... 25, 2017  EpiVax, Inc., a leader in ... immune-engineering today announced the launch of EpiVax Oncology ... personalized therapeutic cancer vaccines. EpiVax has provided $500,000 ... to enabling technologies to the new precision immunotherapy ... EpiVax Oncology as Chief Executive Officer. Gad brings ...
(Date:9/22/2017)... DIEGO , Sept. 22, 2017 AVACEN ... medical device is now successfully helping those with the ... Fibromyalgia diagnosed Amanda in Essex, ... dressed and washing my hair, experiencing no sleep at ... in painful spasm… I cannot recommend [the AVACEN 100] ...
Breaking Medicine Technology: