Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • News
  • Published:

Third oral MS drug wins FDA nod

Nature Biotechnology volume 31, page 373 (2013)Cite this article

Subjects

A Correction to this article was published on 08 October 2013

This article has been updated

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 of subscription content, access via your institution

Access options

Buy this article

  • Purchase on SpringerLink
  • Instant access to the full article PDF.

USD 39.95

Prices may be subject to local taxes which are calculated during checkout

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

  1. Dublin

    Cormac Sheridan

Authors
  1. Cormac Sheridan
    View author publications

    Search author on:PubMed 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:

  • Issue date:

  • DOI: https://doi.org/10.1038/nbt0513-373a

This article is cited by

Search

Advanced search

Quick links

Nature Briefing: Translational Research

Sign up for the Nature Briefing: Translational Research newsletter — top stories in biotechnology, drug discovery and pharma.

Get what matters in translational research, free to your inbox weekly. Sign up for Nature Briefing: Translational Research