FDA Approves Tecfidera for Multiple Sclerosis
On March 27, 2013 the U.S. Food and Drug Administration announced approval of a new drug to treat multiple sclerosis. The drug, Tecfidera (dimethyl fumarate) is approved for use in adult patients relapsing multiple sclerosis (MS).
Tecfidera will be launched in 120 mg and 240 mg delayed release capsule formulations. While the exact mechanism of action of Tecfidera is unknown, it is believed that Tecfidera provides a new approach to treating MS by activating the Nrf2 (nuclear factor erythroid 2-related factor 2) pathway. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.
Common side effects of Tecfidera, as observed in the clinical trials, include Flushing (warmth and redness) and stomach problems (nausea, vomiting, and diarrhea). Tecfidera may also cause a decrease in white blood cell count (lymphocytes), and the FDA has recommended that physicians assess the patient’s white cell count at the start of treatment and at least annually while the patient is being treated.
Tecfidera is marketed by Biogen Idec, and is expected to be priced at a wholesale acquisition cost (WAC) of $54,600 per year for each patient treated with Tecfidera.
For more information, see the FDA’s press release at: FDA Press Release – Tecfidera
Tags: decrease in white blood cell, dimethyl fumarate, flushing, MS, multiple sclerosis, Nrf2, side effects of tecfidera, tecfidera, wholesale acquisition cost