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:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... TopConsumerReviews.com recently ... of Eyeglasses . , Millions of individuals in the United States and Canada ... become a way to both correct vision and make a fashion statement. Even celebrities ...
(Date:6/26/2016)... ... 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop ... The fitness app plans to fix the two major problems leading the fitness industry today:, ... all type program , They don’t eliminate all the reasons people quit their ...
(Date:6/25/2016)... ... ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize each ... Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into hand ... select a ProHand generator and drag it above media or text in the Final ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from PsychTests.com reveals that behind ...
(Date:6/24/2016)... Dallas, Texas (PRWEB) , ... June 24, 2016 ... ... 12th International Conference and Scientific Sessions in Dallas that it will receive two ... Announcement of the grants came as PHA marked its 25th anniversary by recognizing ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 2016 According to a new ... Pen Needles, Safety Pen Needles), Needle Length (4mm, 5mm, ... Mode of Purchase (Retail, Non-Retail) - Trends & Global ... the market for the forecast period of 2016 to ... Billion by 2021 from USD 1.65 Billion in 2016, ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... the appointment of Dr. Edward Futcher ... Non-Executive Director, effective June 23, 2016.Dr. Futcher was ... Nominations and Governance Committees.  As a non-executive member ... independent expertise and strategic counsel to VolitionRx in ...
(Date:6/23/2016)... 23, 2016  MedSource announced today that it ... software solution of choice.  This latest decision demonstrates ... to their clients by offering a state-of-the-art electronic ... establishes nowEDC as the EDC platform of choice ... clients.  "nowEDC has long been a preferred EDC ...
Breaking Medicine Technology: