The FDA ( Food and Drug Administration ) has approved Tecfidera ( Dimethyl fumarate ) capsules to treat adults with relapsing forms of multiple sclerosis.
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 multiple sclerosis, episodes of worsening function ( relapses ) are initially followed by recovery periods ( remissions ). Over time, recovery periods may be incomplete, leading to progressive decline in function and increased disability. Multiple sclerosis patients often experience muscle weakness and difficulty with coordination and balance. Most people experience their first symptoms of multiple sclerosis between the ages of 20 and 40.
Results from two clinical trials showed that those taking Tecfidera had fewer multiple sclerosis relapses compared to people taking a placebo. One of the trials showed that those taking Tecfidera experienced a worsening of disability less often than patients taking a 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 patients white blood cell count be assessed by their health care provider.
Flushing 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. ( Xagena )
Source: FDA, 2013