Aubagio® (Oral Teriflunomide) Receives FDA Approval
September 13, 2012 - Updated: September 17, 2012
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.
According to MSAA's Chief Medical Officer Dr. Jack Burks, "With the recent approval of Aubagio, we now have two oral treatments - for a total of nine treatments all together - for the long-term treatment of MS. With so many effective treatment choices, this emphasizes the need for individuals and their doctors to work together and discuss potential benefits and side effects, in order to choose the best disease-modifying therapy for each patient. Readers may want to refer to MSAA's S.E.A.R.C.H.™ program to learn more about discussing MS disease-modifying therapies. The future for MS patients is brighter than ever with the approval of Aubagio - giving us yet another effective choice in the treatment of MS."
The TOWER efficacy study is also testing 7-mg and 14-mg doses versus placebo. This study of 1,169 individuals with RRMS is completed and data analysis is ongoing. Its primary endpoint is the annualized relapse rate, with a secondary endpoint of time to disability progression. Top-line results of this trial were announced in June, 2012. In the study, patients receiving the higher dose of 14 mg had a 36.3-percent reduction in annualized relapse rate and a 31.5-percent reduction in the risk of 12-week sustained accumulation of disability, compared to placebo. Patients treated with the lower 7-mg dose of Aubagio experienced a 22.3-percent reduction in annualized relapse rate, compared to placebo.
Because of these warnings, physicians must take certain precautions to minimize any risks. With regard to liver injury, blood tests for liver function must be performed within six months prior to starting Aubagio, and then every month for the first six months. With regard to pregnancy, Aubagio may only be prescribed to women of childbearing years if they are using reliable birth control. If liver damage is detected, or if someone becomes pregnant while taking this drug, accelerated elimination of the drug is prescribed. This removes more than 98 percent of the drug within 11 days.
For More Information
Members of the MS community may also call MSAA's Helpline at (800) 532-7667 for additional information and assistance.
Written by Susan Wells Courtney, MSAA Senior Writer and Creative Director
|Last Updated on Monday, 11 March 2013 11:26|