The FDA approved Tecfidera (dimethyl fumarate) capsules for the treatment of adults with relapsing forms of multiple sclerosis (MS).
Multiple sclerosis is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, relapses and initially followed by remissions. Over time, however, periods of remission may be incomplete, leading to a progressive decline in function and increased disability. MS patients often experience muscle weakness and difficulty with coordination and balance. Most people experience their first symptoms of MS between ages 20 and 40.
Results gathered from two clinical trials showed that patients on Tecfidera had fewer MS relapses compared to people taking placebo. One of those trials showed that those taking Tecfidera experienced a worsening of disability less often than patients on placebo.
Tecfidera may decrease a person’s white blood cell count (lymphocytes). Lymphocytes help protect the body from infection and low counts can raise the risk of infection, although no significant increase in infections was seen in patients taking Tecfidera in clinical trials. Before starting treatment, and annually thereafter, the FDA recommends that the patient’s white blood cell count be assessed by their health care provider.
Flushing (warmth and redness) and stomach problems (nausea, vomiting, and diarrhea) were the most common adverse reactions reported by patients receiving Tecfidera in clinical trials, especially at the start of therapy. These side effects may decrease over time.
Tecfidera is made by Biogen Idec, Weston, Mass.