Aubagio™ (Oral Teriflunomide) Receives FDA Approval

On September 12, 2012, Sanofi and its subsidiary Genzyme announced that the United States Food and Drug Administration (FDA) had approved their new drug, Aubagio™ (oral teriflunomide), for relapsing forms of multiple sclerosis (MS). The FDA had accepted their New Drug Application (NDA) in October, 2011. This is the ninth disease-modifying therapy approved by the FDA for the long-term treatment of MS. Of these nine, Aubagio is the second approved medication for MS that is taken orally.

This drug is an immunomodulator that affects the production of T and B cells. It inhibits rapidly dividing cells, including activated T cells, which are thought to drive the disease process in MS. It also may inhibit nerve degeneration by reducing the production of free radicals, possibly decreasing the risk of infections and other complications linked to chemotherapy-like drugs.

Aubagio has been approved in two dose levels: 7 mg and 14 mg. The medication is produced in film-coated tablets and is taken once daily, with or without food. Since the higher dose shows greater effectiveness, this dose may be more frequently prescribed. However, for individuals who may be more sensitive to the drug and experience greater side effects, the 7-mg dose may be more appropriate. The drug is expected to be available beginning October 1st.

To read more please visit the MSAA website.

Please be sure to check back, as the latest edition of MSAA’s magazine The Motivator will soon be available which will include more research news.

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About MSAA

As a national nonprofit organization, the Multiple Sclerosis Association of America is a leading resource for the entire MS community, improving lives today through vital services and support. MSAA provides free programs and services, such as: a toll-free Helpline; award-winning publications including a magazine, The Motivator; website featuring educational videos and research updates; S.E.A.R.C.H.™ program to assist the MS community with learning about different treatment choices; a mobile phone app, My MS Manager™; a resource database, My MS Resource Locator; equipment distribution ranging from grab bars to wheelchairs; cooling accessories for heat-sensitive individuals; educational events and activities; MRI funding and insurance advocacy; and more. For additional information, please visit http://www.mymsaa.org or call (800) 532-7667.

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