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FDA Approves New Multiple Sclerosis Drug Aubagio

By Matt McMillen
WebMD Health News

Reviewed by Laura J. Martin, MD

Sept. 13, 2012 -- The FDA has approved Aubagio (teriflunomide), a new drug for the treatment of multiple sclerosis (MS). The once-a-day tablet will be prescribed to adults with relapsing forms of the chronic, incurable disease.

In a two-year study, the Aubagio reduced yearly relapses by nearly a third compared to placebo. It also slowed the progression of the disease.

"We are greatly encouraged to see a new oral therapeutic option become available to people living with MS," said Timothy Coetzee, PhD, chief research officer at the National MS Society, in a news release issued by the drug's developer, Genzyme.

MS is the most common disabling neurological disease among young adults, according to the National Institute of Neurological Disorders and Stroke. About 400,000 people in the U.S. have MS. As many as two-thirds of them are women. The disease is usually diagnosed between the ages of 20 and 50.

MS often gradually worsens over time. It causes fatigue, pain, vision and muscle problems, and other difficulties.

Warnings and Side Effects

Aubagio does not come without risks. The drug's label will include a boxed warning that alerts to the risk of potentially fatal liver problems. The label advises that patients' liver function should be tested before starting Aubagio and while on the drug.

The box warning also mentions the risk of birth defects. Women should not be pregnant when they start the drug and must use birth control while taking it.

Other possible side effects include diarrhea, abnormal liver tests, nausea, and hair loss.

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SOURCES: News release, FDA. News release, Genzyme. National MS Society. National Institute of Neurological Disorders and Stroke: "Multiple Sclerosis: Hope Through Research."

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