FDA Approves First MS Oral Treatment

The U.S. Food and Drug Administration (FDA) has approved Gilenya, the first oral treatment for multiple sclerosis (MS). For years, the only treatments for patients with MS had to be injected. In MS, the body’s immune system attacks myelin, a substance that protects nerves. Gilenya works by holding certain immune cells in the lymphnodes so they can’t reach the myelin. In clinical studies, Gilenya reduced MS relapses by 54 percent compared with a placebo and by 52 percent compared with another common injectable drug. However, because there are not many patients yet on the drug, the long-term effects are unknown. And, Gilenya can cause serious side effects such as slowed heart rate, liver problems, headaches and a buildup of fluid in the eye. Currently, four other oral medications are in the final phase of clinical testing that could soon become FDA approved.