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.

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."

Study Results
The TEMSO trial for relapsing-remitting MS (RRMS) compared 7 mg and 14 mg of Aubagio in 1,088 individuals. Both doses significantly reduced the annualized relapse rate by approximately 31 percent. The 7-mg dose resulted in a 39.4-percent reduction in brain-lesion volume on MRI compared with placebo; the 14-mg dose resulted in a 67.4-percent reduction. The 14-mg dose also reduced the risk of sustained disability progression by 29.8 percent relative to placebo. The number of gadolinium-enhancing lesions was reduced with both doses compared with placebo, and there was a trend toward a greater effect with the higher dose.

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.

Adverse Events
Common adverse events include headache, elevations in liver enzymes, hair thinning, diarrhea, nausea, neutropenia (a condition that reduces the number of certain white blood cells that normally fight infection), and paresthesia (tingling, burning, or numbing sensation). More severe adverse events include the risk of severe liver injury and the risk of birth defects if used during pregnancy. A "black box" warning appears on the labeling of Aubagio, which lists these two risks.

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
For more information about Aubagio, members of the MS community may visit www.aubagio.com. Individuals may also contact Genzyme's "MS One to One" program, which provides access to nurses experienced with MS patients on Genzyme treatments. This service may be accessed by calling (855) MSOne2One - or (855) 676-6326, Monday through Friday from 8:30 am to 8:00 pm ET. Information and support is also available at www.MSOnetoOne.com. Financial assistance will be available to individuals who qualify.

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
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer