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.

In MS, the body's own immune system attacks the layer of fatty tissue, called the myelin sheath, that surrounds and protects the nerves of the central nervous system (brain and spinal cord). The immune system's attacks erode the myelin sheath, producing scar tissue (sclerosis) and disrupting communication between the central nervous system and the rest of the body. Problems with sensation, strength, vision, and sometimes thinking can result. Relapsing forms of the disease are characterized by episodes of worsening symptoms, followed by periods of complete or partial recovery (remissions). For reasons that aren't clear, MS is two to three times more common in women than in men.

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