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FDA approves Tecfidera to treat multiple sclerosis

Robin Wulffson MD's picture
multiple sclerosis, (MS, autoimmune disease, Tecfidera, treatment

Multiple sclerosis (MS) is a progressive autoimmune disease of the central nervous system that affects about 400,000 people in the United States. It disrupts communication between the brain and other parts of the body. On March 27, the Food and Drug Administration approved Tecfidera (dimethyl fumarate; Biogen Idec, Weston, Massachusetts ) capsules to treat adults with relapsing forms of the disease.

Although the FDA approval offers new hope for MS sufferes, the FDA cautions that the drug is by no means curative. “No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients,” explained Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. He added, “Multiple sclerosis can impair movement, sensation, and thinking and have a profound impact on a person’s quality of life.”

The FDA reports that results from two clinical trials showed that those taking Tecfidera had fewer MS relapses compared to people taking a placebo. In addition, one of the trials reported that those taking Tecfidera experienced a worsening of disability less often than patients taking a placebo. Like most drugs, Tecfidera has significant side-effect. The medication 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; however, no significant increase in infections was seen in patients taking Tecfidera in clinical trials.

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Before starting treatment, and annually thereafter, the FDA recommends that the patient’s white blood cell count be assessed by their healthcare provider. Te most common side-effects reported with the drug were 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.

MS 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, 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. MS patients often experience muscle weakness and difficulty with coordination and balance. Most people experience their first symptoms of MS between the ages of 20 and 40.

Tecfidera take home message:

As the FDA notes, Tecfidera is not curative; however, it might slow progression of multiple sclerosis. Holding more promise are studies that reprogram skin cells to tackle the root of the problem, which is a loss of the protective myelin sheath around nerve cells. On February 7, researchers affiliated with the University of Rochester Medical Center in Rochester, N.Y. reported that they had converted human skin cells into brain cells and used them to treat mice with myelin disorders, which are a family of diseases that includes MS. They reported their findings on February 7 in the journal Cell Stem Cell. The study falls on the heels of another study with pluripotent cells by UCLA stem cell researchers. The study was published on December 7, 2012 in the early online edition of the inaugural issue of the peer-reviewed journal Stem Cells Translational Medicine. The researchers reported that, by using a specially designed facility, they had reprogrammed human skin cells to be pluripotent and then differentiated them into neurons, using animal origin-free reagents and feeder conditions throughout the process.

Reference: FDA