Harvard Women's Health Watch

In the news: FDA approves the first oral drug for reducing multiple sclerosis relapses

People with relapsing forms of multiple sclerosis (MS) have a new option for reducing periodic attacks (relapses) and for delaying the progression of MS-related disability. MS is typically treated with injected drugs or infusions, which can be painful and inconvenient and may discourage some patients from staying on therapy. The FDA has approved the first oral medication, fingolimod, brand name Gilenya (pronounced jil-EN-yah).

The drug, taken once a day in 0.5-milligram (mg) capsules, works by a different mechanism than other approved MS medications, and in a head-to-head comparison, it was more effective against relapses than one of the leading injectables. However, fingolimod has a number of side effects — some potentially quite serious — and its long-term safety and effectiveness are unknown.

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