Tecfidera Approved for Multiple Sclerosis
THURSDAY, March 28 -- Tecfidera (dimethyl fumarate) capsules have been approved by the U.S. Food and Drug Administration to treat relapsing forms of multiple sclerosis (MS).
MS is an autoimmune disease where your body mistakenly attacks and damages the protective covering around your nerve cells. Signals between your brain and body are slowed or blocked altogether by this damage. Most people with the disease have relapses, followed by periods of remission, the FDA said in a news release. Among the most common causes of neurological disability, the disease affects more women than men, often beginning between the ages of 20 and 40.
Common symptoms of MS include muscle weakness and problems with coordination and balance.
Two clinical trials of Tecfidera demonstrated that people who took the drug had fewer MS relapses than those who took a placebo, the agency said. Recorded side effects included a decrease in white blood cells, flushing and gastrointestinal problems.
Tecfidera is manufactured by Biogen Idec, of Weston, Mass.
The U.S. National Library of Medicine has more about MS.
Posted: March 2013