According to a story from tmcnet.com, Alkermes plc and Biogen, Inc. have recently announced that the US Food and Drug Administration (FDA) has approved a new treatment for multiple sclerosis. The new medication, called diroximel fumerate (marketed as VUMERITY) is designed for the treatment of a variety of relapsing forms of the disease, including active secondary progressive multiple sclerosis, clinically isolated syndrome, and the most common relapsing-remitting variant.
About Multiple Sclerosis (MS)
Multiple sclerosis is a neurological disease which is characterized by damage to the myelin sheath, a fatty, insulating, protective covering that surrounds nerve cells and allows them to communicate effectively. Although a precise cause has not been determined, multiple sclerosis is considered an autoimmune disease, in which a certain trigger, such as an infection, may cause the immune system to mistakenly attack healthy tissue. Smoking and certain genetic variants are also considered risk factors for the disease. Symptoms include blurred vision, double vision, blindness in one eye, numbness, abnormal sensations, pain, muscle weakness, muscle spasms, difficulty speaking and swallowing, mood instability, depression, loss of coordination, and fatigue. There are a number of treatments available for the disease, but no cure. Life expectancy for patients is slightly reduced. To learn more about multiple sclerosis, click here.
VUMERITY is similar to another treatment for the disease called dimethyl fumarate (marketed as TECFIDERA). While effective, many patients struggle with serious gastrointestinal side effects when using it. VUMERITY is designed to have the same clinical effect as TECFIDERA without these side effects. The New Drug Application included data that established “bioequivalence” between the two medications. In clinical trials testing VUMERITY, only 6.3 percent of patients had to stop treatment because of adverse effects, and of this percentage less than one percent stopped because of gastrointestinal problems.
With this approval, multiple sclerosis patients will now have access to a new treatment that promises both clinical efficacy and reduced side effects, which has the potential to have a positive effect on patient quality of life. As a chronic, progressive disease, patients are expected to take medication for a long time, often the rest of their lives. Therefore, tolerability is just as important as clinical impact.