FDA approves Biogen Idec’s Tecfidera for multiple sclerosis
The FDA has approved Biogen Idec’s Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
"No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients," said Russell Katz, M.D., director of the division of neurology products in the FDA's Center for Drug Evaluation and Research. "Multiple sclerosis can impair movement, sensation and thinking, and have a profound impact on a person's quality of life."
Results from two clinical trials showed that those taking Tecfidera had fewer MS 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. The most common adverse reactions were flushing, nausea, vomiting and diarrhea, especially at the start of therapy. These side effects may decrease over time.