Tecfidera (dimethyl fumarate) capsules have just been approved by the U.S. Food and Drug Administration (FDA) to treat adults with relapsing forms of multiple sclerosis (MS).
MS is an autoimmune disease of the central nervous system that is known for being persistent and inflammatory. People affected by the illness experience a disruption in communication between their brain and other parts of their body.
It is one of the most common causes of neurological disability in young adults and occurs more often in females than males. A previous study found that the risk of MS in women increases with certain environmental factors, including smoking, viral infections, hygiene changes, dietary factors, and vitamin D deficiency.
The majority of MS patients go through bouts of worsening function, known as relapses, that are at first followed by recovery periods called remissions. Prior research showed that MS patients who receive fertility treatment have higher relapse rates.
Over time, periods of recovery may become less restorative, resulting in progressive decline in function and increased disability.
Muscle weakness and problems with balance and coordination are commonly experienced by people with the disease. The majority of patients are faced with their first symptoms of MS when they are between 20 and 40 years old.
Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said:
“No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients. Multiple sclerosis can impair movement, sensation, and thinking and have a profound impact on a person’s quality of life.”
After conducting two clinical trials, the scientists found that the patients taking Tecfidera had fewer MS relapses than those taking a placebo (inactive pill).
One of the trials demonstrated that people taking Tecfidera suffered a worsening of disability less frequently than those taking a placebo.
The Agency warned that a person’s white blood cell count (lymphocytes) may reduce as a result of the treatment with Tecfidera. Lymphocytes help keep the body safe from infection, which means that low counts may increase the likelihood of developing an infection. However, the experts explained, no significant increase in infections was found among those taking Tecfidera in clinical trials.
The FDA advises that prior to starting treatment, and each year after, the patient’s white blood cell count should be evaluated by his/her health care provider.
The most common adverse reactions reported by patients taking Tecfidera in trials, particularly at the beginning of treatment, include:
- flushing – warmth and redness
- stomach problems – nausea, vomiting, and diarrhea
Over time, these side effects may decrease, according to the scientists.
In September 2012, the FDA approved Aubagio (teriflunomide), a once-daily tablet for adults with relapsing forms of MS (multiple sclerosis). In a clinical trial, the relapse rate for patients taking Aubagio was about 30% lower compared to those on placebo.
Written by Sarah Glynn