The U.S. Food and Drug Administration has approved Aubagio® (teriflunomide), a once-daily tablet, to treat relapsing forms of MS. The therapy is expected to be available for prescription by October 1, 2012 in theU.S.
“In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent 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.
The most common side effects of Aubagio experienced by participants 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.
Aubagio will be dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information. Aubagio is made by Bridgewater, N.J.-based Sanofi Aventis.
Physicians and people with MS can contact Genzyme for information about Aubagio and patient support programs by calling: 1-855-676-6326, or visit the company’s Website: www.MSOnetoOne.com.