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.
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