Tecfidera (BG-12) awaits FDA decision

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January 31, 2013

Tecfidera (BG-12) is pending FDA decision on March 27, 2013. This oral twice daily treatment for multiple sclerosis has been demonstrated to drop relapses by 53% in the DEFINE trial. In addition, Tecfidera reduced the likelihood of disability worsening by 38% compared to placebo. The impact was robust on MRI with 90% less new contrast activity. New or enlarging T2 areas on MRI were reduced by 85%. Common side effects include flushing, nausea, vomiting, and diarrhea which generally improve after one month. High blood liver tests and low white blood counts were also noted in the trial.

In the CONFIRM Trial, the twice a day dose of Tecfidera lowered relapses by 44% compared to placebo. In a comparison group of patients in the trial, Copaxone reduced relapses by 29%. Tecfidera is an oral formulation of dimethyl fumurate, which has been demonstrated to reduce inflammation and protect cells in experimental research. Dimethyl fumarate is a component of the drug Fumaderm, used to treat psoriasis in Germany.

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