FDA Approves First Oral Medication for Multiple Sclerosis

This week the US Food and Drug Administration approved the release of fingolimod (trade name Gilenya®), the first oral medication for the treatment of remitting relapsing multiple sclerosis. Swedish Neuroscience Institute is proud to have participated in the pivotal clinical trial that led to the approval of Gilenya. Gilenya is a welcome addition to the set of medications available to patients living with MS. There are currently five injectable therapies and two intravenous therapies approved by the FDA for the treatment of MS. Although these treatments are very effective, many patients have been hoping for an oral alternative. Some patients are finding that they have “injection fatigue” or are running out of places to inject the medication. It is important to note, however, that not all patients should switch to Gilenya. Patients with stable disease should remain on their medications. Patients need to be informed of the risks associated with Gilenya, including slowed heart rate, increased blood pressure, difficulty breathing, abnormal liver function, and infection, and how these risks may apply to them. If you are wondering whether Gilenya is right for you, please ask your neurologist.