FDA approves new multiple sclerosis treatment Aubagio

Genzyme

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Genzyme

(CBS News) The U.S. Food and Drug Administration (FDA) approved a new medication for the treatment relapsing forms of multiple sclerosis on Thursday.

Aubagio (teriflunomide) is a once-a-day tablet made by Genzyme, a subsidiary of Sanofi Aventis, that is intended for the treatment of adults with the disease.

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"In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo," Dr. Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a press release. "Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients."

Multiple sclerosis - commonly known as MS - is a chronic, inflammatory autoimmune disease that attacks the central nervous system by blocking communication between the brain and body parts, the FDA said. The National Multiple Sclerosis Society estimates that 400,000 Americans have MS, with 200 new people diagnosed with the disease each week. Around the globe, 2.1 million people are living with the disease. Most people begin experiencing MS symptoms between the ages of 20 and 40, according to the National Institutes of Health.

The FDA added that MS is one of the most common cases of neurological disability in young adults and occurs twice as frequently in women compared to men. Most people with MS have times with worsening function known as relapses and then periods with no little or no symptoms called remission. Over time, however remission periods may shorten leading to continued decline in body functions and can cause complete or partial paralysis.

Recently, a study showed that the commonly prescribed injection, interferon beta, did not stop the progression of MS, but may benefit patients in other ways including reducing relapse. There is no cure for the disease currently.

People taking Aubagio may experience diarrhea, abnormal liver tests, nausea, and hair loss, and there is a boxed warning that describes an increased risk of liver problems, including death, and a risk of birth defects. Tests on animals have shown that it may cause fetal harm, so patients cannot be pregnant while on the tablet.The FDA recommends that doctors perform a blood test to check liver function before putting patient on the medication.

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