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March 27, 2013

Biogen’s MS drug gets FDA approval

The US Food and Drug Administration has approved Biogen Idec's Tecfidera capsules for the treatment of relapsing forms of multiple sclerosis.

By Nikitha Ladda

brain

The US Food and Drug Administration has approved Biogen Idec‘s Tecfidera capsules for the treatment of relapsing forms of multiple sclerosis.

The US-based biotechnology company said it will make the oral drug available in the coming days.

Results from two clinical trials showed that participants taking Tecfidera (dimethyl fumarate) had fewer MS relapses compared to those taking a placebo.

One of the trials also showed that patients taking Tecfidera experienced a worsening of disability less often than those taking an inactive pill.

Biogen CEO George Scangos said; "With the FDA approval of Tecfidera, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have a significant positive impact on the way people live with this chronic disease."

Tecfidera may decrease white blood cell count (lymphocyte) in some patients, Biogen warned.

In clinical studies, mean lymphocyte counts decreased during the first year of treatment and then remained stable.

FDA Center for Drug Evaluation and Research Division of Neurology Products director Dr Russel Katz commented on the approval; "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."


Image: Multiple sclerosis is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged. Image courtesy of FreeDigitalPhotos.net.

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