FDA Approves Oral Drug to Treat Multiple Sclerosis

First Posted: Mar 28, 2013 07:23 AM EDT
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The company Biogen Idec has won the approval of the U.S. Food and Drug Administration for its drug to treat adults with relapsing forms of multiple sclerosis (MS), which affects the person's central nervous system. The drug, called 'Tecfidera', is the company's third approved drug but is the first drug to be in the form of a pill.

"No drug provides a cure for multiple sclerosis 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 press statement. "Multiple sclerosis can impair movement, sensation, and thinking and have a profound impact on a person's quality of life."

MS, which is the most common cause of neurological disability in young adults, disrupts communication between the brain and other parts of the body.  It mostly occurs in women as compared to men.  Victims of MS notice muscle weakness and have a tough time with coordination and balance. It appears in the early age of 20-40. In most MS patients, occurrences of worsening function (relapses) are firstly followed by recovery periods (remissions).

FDA approved the drug Tecfidera based on two studies which revealed that patients suffering from MS had fewer relapses than those taking a placebo. Apart from this, one study even showed that on consuming the drug Tecfidera, the MS patients experienced a reduction in the worsening of the disability than those taking the inactive pill.

The side effects on consuming the new drug Tecfidera are flushing, that occurred in nearly 40 percent of the patients, stomach problems such as diarrhea, vomiting and nausea.

Biogen's other MS drugs include Avonex, which had global sales of $2.9 billion last year, and Tysabri, which had sales of $1.1 billion, reports The Wall Street Journal. 

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