First Oral Drug Approved to Reduce Relapses in MS

The FDA has approved fingolimod (Gilenya), the first oral drug used to treat relapsing forms of multiple sclerosis.

The once-daily, 0.5-mg capsules "can slow the progression of disability and reduce the frequency and severity of symptoms in MS," according to the agency's Center for Drug Evaluation and Research. The drug works by preventing lymphocytes from exiting lymph nodes, which keeps them from migrating to the brain and spinal cord.

The most common adverse effects of fingolimod include elevated liver enzymes, influenza, headache, back pain, cough, and diarrhea. In clinical trials leading to the drug's approval, some patients experienced macular edema and herpes infections. Patients should initially be monitored for decreased heart rate.

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