TribLIVE

| USWorld


 
Larger text Larger text Smaller text Smaller text | Order Photo Reprints

FDA grants approval for multiple sclerosis medication

Daily Photo Galleries

By The Los Angeles Times
Thursday, March 28, 2013, 6:33 p.m.
 

WASHINGTON — An oral medication for multiple sclerosis has won the Food and Drug Administration's marketing approval and is to become available almost immediately to patients suffering from the debilitating auto-immune disease.

Tecfidera is the commercial name for dimethyl fumarate, a capsule that won the FDA's blessing this week as a treatment for relapsing MS, a degenerative brain disorder that can impair mobility, sensation and thinking.

In clinical trial evidence submitted to the FDA by Biogen Idec of Weston, Mass., the medication's maker, Tecfidera reduced the proportion of patients who relapsed when compared with a sham medication. In one of those trials, subjects taking Tecfidera showed less progression of the disease compared with those on a placebo. And both trials found that those taking Tecfidera twice daily developed fewer MS-related lesions in the brain.

The medication was formerly known as BG-12.

Those findings held whether patients had newly diagnosed multiple sclerosis or had their multiple sclerosis progress over some years, said Dr. Robert M. Fox, medical director of the Mellen Center for Multiple Sclerosis at the Cleveland Clinic, in a statement issued by Biogen Idec. Fox serves as a paid adviser to the firm and was lead investigator in one of the Tecfidera's earliest trials.

Common side effects of Tecfidera are flushing and gastrointestinal events, including nausea, diarrhea and vomiting. And though no increased rate of infections were noted in those taking Tecfidera in clinical trials, the medication may lower white blood counts and increase infection risk, the FDA said.

Subscribe today! Click here for our subscription offers.

 

 
 


Show commenting policy

Most-Read Nation

  1. Ramping up e-cigarette voltage may be more hazardous to health
  2. Obama to seek protection of wilderness designation for Alaska refuge
  3. Arizona hospital tests brain tumor drugs by giving patients dose, then operating
  4. New York father kils 3 generations of family, himself
  5. Snowstorm crawls up coast, hitting New York, New Jersey, Connecticut, parts of Pennsylvania
  6. Gunfire kills 3 at party in vacant house in Omaha
  7. Rosetta spacecraft providing data on its comet traveling partner
  8. Vanderbilt University gang-rape defense points to campus culture
  9. Grandma thwarts Oregon purse-snatcher who can’t shake her off car
  10. Marine Corps’ general outlines priorities, vision
  11. Boy, 13, arrested in fatal stabbing at David Wark Griffith Middle School in East Los Angeles