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Access through your institution Buy or subscribe Biogen Idec's oral multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate) represents one of the most unusual major product launches
in recent years. Formerly known as BG-12, Tecfidera was approved on March 27 by the US Food and Drug Administration (FDA)—and is likely to be approved soon by the European Commission. It
comes with a hefty annual price tag of $54,900 in the US and has attracted multibillion dollar revenue forecasts because of its promising phase 3 data, which suggest it offers patients an
attractive combination of efficacy and safety. Although there is some evidence that Tecfidera, a simple and tiny small molecule, may work by activating the cytoprotective nuclear factor
erythroid 2–related factor 2 (Nrf2)-signaling pathway, which has anti-inflammatory and anti-oxidative effects, its precise molecular target and mechanism of action remain unclear. In that
respect, it resembles the older generation of injectable drugs, including the ABCR drugs. However, its efficacy and tolerability profile sets it apart from these products. This is a preview
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ADDITIONAL ACCESS OPTIONS: * Log in * Learn about institutional subscriptions * Read our FAQs * Contact customer support CHANGE HISTORY * _ 13 MAY 2013 In the version of this article
initially published, the headline referred to “Second oral MS drug....” The drug Tecfidera is the third oral MS drug to win FDA approval. The error has been corrected in the HTML and PDF
versions of the article. _ AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Dublin Cormac Sheridan Authors * Cormac Sheridan View author publications You can also search for this author
inPubMed Google Scholar RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Sheridan, C. Third oral MS drug wins FDA nod. _Nat Biotechnol_ 31, 373 (2013).
https://doi.org/10.1038/nbt0513-373a Download citation * Published: 08 May 2013 * Issue Date: May 2013 * DOI: https://doi.org/10.1038/nbt0513-373a SHARE THIS ARTICLE Anyone you share the
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