Key Points

• Yes, Aubagio (teriflunomide) was approved by the FDA in 2012 for treatment of patients with relapsing forms of multiple sclerosis (MS).
• MS is a long-term medical condition in which your immune system attacks your central nervous system.
• Aubagio comes an oral tablet given once a day, with or without food.

Aubagio works in MS by inhibiting pyrimidine synthesis leading to decreased inflammation, reduced white blood cells in the CNS, and nerve protection in MS.

Aubagio comes as an oral tablet in two strengths: 7 mg or 14 mg. It is taken orally once daily with or without food.

In the TEMSO clinical trial submitted to the FDA for approval, Aubagio significantly reduced:

• Annualized MS relapse rates at both doses of 7 or 14 mg once a day.
• Disability progression at the higher 14 mg dose (27.3% with placebo and 20.2% with teriflunomide).
• MRI evidence of disease activity, as compared with placebo.

However, in this, study there was a high drop-out rate for all active and placebo groups, ranging from 25% to 29% of participants.

The most common side effects with Aubagio include:

• elevated liver enzymes
• alopecia (hair loss)
• diarrhea
• influenza
• nausea
• paresthesia (numbness or burning sensation in legs, hands, arms, or feet).

What is MS?

Scientists believe that MS begins as an inflammatory immune-mediated disorder causing the body's immune system to attack the protective myelin sheaths around nerves in the central nervous system, which includes the brain, spinal cord, and optic nerve.

When the myelin sheath is damaged it forms scar tissue -- also called sclerosis -- which disrupts the flow of nerve impulses, causing the symptoms of MS. Symptoms of MS can include numbness or weakness in one or more limbs, tremor, unsteady gait, vision problems, blurred vision, slurred speech, fatigue, dizziness, problems with sexual, bowel and bladder function.

The nerve damage that occurs with MS is not reversible or curable. However, early medical treatment and lifestyle changes can have a positive impact on a patient's quality of life.

Most people with MS will live a normal life-span.

Bottom Line

• Aubagio (teriflunomide) was approved by the FDA in 2012 to treat relapsing forms of multiple sclerosis. It comes as an oral tablet taken one time a day.
• Aubagio is an immunomodulator drug that works in MS by decreasing inflammation, lowering the number of white blood cells in the central nervous system, and protecting the nerves.
• Aubagio has been shown to decrease relapse rates in MS, slow disability progression, and reduce the number of brain lesions as detected by MRI.

This is not all the information you need to know about Aubagio (teriflunomide) for safe and effective use. Review the full Aubagio information here, and discuss this information with your doctor or other health care provider.