FDA Approves Twice a Day Capsules Called Tecfidera (Formerly Called BG-12) for Relapsing MS
[Targeted News Service]
NEW YORK, March 27 -- The National Multiple Sclerosis Society issued the following news:
The U.S. Food and Drug Administration has approved Tecfidera capsules (dimethyl fumarate, Biogen Idec -formerly "BG-12") as a first-line disease-modifying therapy for people with relapsing forms (http://www.nationalmssociety.org/about-multiple-sclerosis/relapsing-ms/i...) of MS.
This makes the third oral therapy approved for relapsing MS, and the tenth disease-modifying treatment available in the U.S. Tecfidera is expected to be available by prescription within a few days.
"The approval of Tecfidera is an important expansion of therapeutic options, and increases our ability to find effective and tolerable treatment solutions for individual patients," said Bruce A. Cohen, MD, Professor, Davee Department of Neurology and Clinical Neurosciences at Northwestern University's Feinberg School of Medicine, and Chair of the National MS Society's National Medical Advisory Committee.
"As with all newly-approved treatments, we will learn more about the benefits and safety of Tecfidera over time," he added.
"The approval of Tecfidera is encouraging news for people who have relapsing forms of MS," noted Timothy Coetzee, PhD, Chief Research Officer at the National MS Society. "Having ten disease-modifying therapies available for relapsing forms of MS further motivates us to gather the forces of the global community to make similar strides for people with progressive forms of MS, for whom there are fewer options."
Read more (www.nationalmssociety.org/news/news-detail/download.aspx?id=45592) about the International Progressive MS Collaborative (.pdf)
Read (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345528.htm) the FDA's press release.
About Tecfidera: Multiple sclerosis involves immune system attacks against brain and spinal cord tissues. Although its exact mechanism of action is not known, Tecfidera is thought to inhibit immune cells and molecules, and may have anti-oxidant properties that could be protective against damage to the brain and spinal cord. A chemically related compound, called Fumaderm (dimethyl fumarate and fumeric acid esters), has been used for decades in Germany to treat acute flare-ups of psoriasis. Tecfidera is a new, different formulation of dimethyl fumerate that was developed by Biogen Idec specifically for the treatment of multiple sclerosis.