Aubagio gets FDA Approval

Sep 12 2012

Aubagio (teriflunomide) is a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).  The Aubagio 14 mg dose has been shown to reduce relapses by 31.5% in the TEMSO trial and 36% in the TOWER trial.  Both trials demonstrated a benefit in reducing the likelihood of disability progression.  In the TEMSO trial, new active MRI lesions with contrast were reduced by 80% with treatment with 14 mg of Aubagio.  The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair thinning.

Leflunomide, a treatment for rheumatoid arthritis,  is converted in the body to teriflunomide.  Globally since the launch of leflunomide, 2.1 million years of patient exposure has occurred. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide.  Aubagio contains a Boxed Warning to alert prescribers and patients to the risk of liver problems, including death, and a risk of birth defects. Physicians should do blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment.  Based on animal studies, the drug may cause fetal harm. For this reason, Aubagio is labeled as Pregnancy Category X, which means women of childbearing age must have a negative pregnancy test before starting the drug and use effective birth control during treatment.  [Warnings per FDA 9/12/12 press release]

The MS Center for Innovations in Care at Missouri Baptist Medical Center has been a site for the TOWER trial of Aubagio.

BY: Barry Singer, MD DATE: September 12, 2012 TOPIC: MS Research News