FDA Approves Tecfidera for Multiple Sclerosis
Trial finds that drug helps prevent relapses compared with placebo
THURSDAY, March 28 (HealthDay News) -- Tecfidera (dimethyl fumarate) capsules have been approved by the U.S. Food and Drug Administration to treat relapsing forms of multiple sclerosis (MS).
Among the most common causes of neurological disability, MS 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. Most people with the disease have relapses, followed by periods of remission, the FDA said in a news release.
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.
"No drug provides a cure for MS so it is important to have a variety of treatment options available for patients," Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "MS can impair movement, sensation, and thinking and have a profound impact on a person's quality of life."
Tecfidera is manufactured by Biogen Idec, of Weston, Mass.