Friday, September 14, 2012
The FDA has approved Sanofi Aventis’ Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).
“In a clinical trial, the relapse rate for patients using Aubagio was about 30% lower than the rate for those taking a placebo,” said Russell Katz, M.D., director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research (CDER). “Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.”
The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea and hair loss. The drug 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.
Also included in the Boxed Warning is an alert noting that, 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.