FDA Approves Aubagio (Teriflunomide) for Multiple Sclerosis
Labeling includes boxed warnings (Sept. 12)
The FDA announced on September 12 that it has approved Aubagio (teriflunomide), a once-daily 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 placebo.
MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline.
The most common side effects of Aubagio observed in clinical trials include diarrhea, abnormal liver tests, nausea, and hair loss.
The drug’s labeling includes a boxed warning to alert prescribers and patients to the risk of liver problems, including death, and a risk of birth defects. Physicians should perform 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 must use effective birth control during treatment.
Aubagio is an immunomodulatory, disease-modifying oral drug with anti-inflammatory properties. It works by blocking the proliferation and functioning of activated B and T lymphocytes (thought to be damaging in MS) by selectively and reversibly inhibiting a critical mitochondrial enzyme.
Aubagio is made by Sanofi Aventis, based in Bridgewater, N.J.
For more information, visit the FDA Web site.