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FDA Approves Oral Drug for Relapsing Multiple Sclerosis

Brain silhouettes (


The U.S. Food and Drug Administration approved yesterday teriflunomide, a tablet taken once a day for the treatment of adults with relapsing forms of multiple sclerosis. The drug, marketed under the name Aubagio, was developed by the Genzyme division of the French pharmaceutical company Sanofi-Aventis in Cambridge, Massachusetts.

Multiple sclerosis is an autoimmune disease of the brain and spinal cord, affecting women more than men, and often diagnosed between ages 20 and 40. People with multiple sclerosis often experience periods of relapse or worsening function, followed by recovery, but recoveries can be incomplete, which over time can lead to a progressive decline.

The disorder is caused by damage to the myelin sheath that protects and surrounds nerve cells, slowing or disrupting nerve signals. Damage to the nerve is caused by inflammation, which occurs when immune cells attack the nervous system. This inflammation can occur in any part of the brain, optic nerve, and spinal cord.

Aubagio, says Genzyme, acts to modulate the immune system as well as reduce inflammation. The company believes the drug reduces the number of activated lymphocytes — white blood cells in the immune system — in the central nervous system, although the precise way the drug works is not fully known.

FDA says it based the approval on results from a phase 3 clinical trial where patients with relapsing forms of multiple sclerosis using Aubagio had about a 30 percent lower relapse rate than those taking a placebo. The results indicate Aubagio in 14 milligram doses significantly reduced the annualized relapse rate and lengthened the time patients progressed to disability over two years, than those taking a placebo. The findings also showed Aubagio doses of 7 milligrams significantly reduced the annualized relapse rate. Genzyme says early findings from another clinical trial of Aubagio show similar results.

The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair loss. The drug has a prominently labeled warning about risks of liver problems, birth defects, and potential fetal harm.

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Hat tip: MedCity News

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