Aubagio Approved for Treatment of Adults with Relapsing Multiple Sclerosis

New Drugs , News / October 1, 2016

The FDA approved Aubagio (teriflunomide) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Aubagio is a once-a-day tablet.

MS is a chronic inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. MS can impair movement, sensation, and thinking; and 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, relapses are initially followed by remissions; however, over time periods of remission may be incomplete, leading to a progressive decline.

In a clinical trial the relapse rate for patients using Aubagio was about 30% lower than the rate for those taking a placebo.

The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair loss.

Aubagio contains a Boxed Warning alerting healthcare professionals and patients to the risk of liver problems, including death, and a risk of birth defects. Blood tests should be carried out to check liver function prior to initiation of Aubagio treatment and during treatment on a periodic basis.

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 C, which means that women of childbearing age must have a negative pregnancy tests before starting the drug and use effective birth control during the treatment.

Aubagio is a product of Bridgewater, N.J.-based Sanofi Aventis.

No Comments

Leave a Reply

%d bloggers like this:
Skip to toolbar