The FDA approves Biogen’s multiple sclerosis treatment

The FDA announced yesterday that it has approved Biogen’s Tecfidera (dimethyl fumarate) capsules for treating adults with relapsing forms of multiple sclerosis (MS).

Two clinical trials demonstrated that patients taking Tecfidera for the chronic, inflammatory, autoimmune disease had fewer MS relapses compared with those taking placebo.

“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.”

Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

Tecfidera may decrease a person’s lymphocytes, however there was no significant increase in infection seen in patients taking Tecfidera in the clinical trials. The FDA has recommended that before starting treatment, and annually thereafter, the patient’s white blood cell count be assessed.