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FDA Approves 1st Oral Drug to Reduce MS Relapses
Date:9/22/2010

By Serena Gordon
HealthDay Reporter

WEDNESDAY, Sept. 22 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday approved the first oral drug to reduce relapses of multiple sclerosis, the nervous system disorder that has traditionally been treated with injectable drugs.

Gilenya (fingolimod) is designed to reduce relapses and delay the progression of debilitating symptoms in patients with relapsing forms of multiple sclerosis (MS). The drug, which works by altering the immune system response, will be available in capsule form.

Research published in January in the New England Journal of Medicine found that Gilenya reduced relapse rates in people with relapsing-remitting multiple sclerosis. However, as is often the case with immune-suppressing medications, there were concerns about side effects, including an increased risk of serious infections and, possibly, cancer.

"Oral drugs are what people with MS have been wishing for a long time. This is wonderful news for people with MS," Dr. John Richert, former executive vice president of research and clinical programs for the National Multiple Sclerosis Society, told HealthDay at the time the research was published. The drug appears to be "quite effective," and at the moment, appears to have a reasonable risk-benefit ratio. "However," he added, "it will be very important for people with MS and their physicians to remain vigilant and be on the lookout for side effects."

The January research was funded by the drug's manufacturer, the Swiss pharmaceutical company Novartis.

Multiple sclerosis is a chronic, potentially disabling illness that's believed to be an autoimmune disorder. In MS, the body's natural defense system mistakenly attacks the fatty substance that protects the nerves (myelin) in the brain and spinal cord. About 400,000 Americans have multiple sclerosis, which is characterized by periods of well-being followed by period
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