FDA News - Approves new MS treatment

Posted September 13, 2012

FDA approves new multiple sclerosis treatment Aubagio – making it the second oral therapy that will be available on the U.S. market. Most MS treatments are injectables.

The U.S. Food and Drug Administration approved Aubagio (teriflunomide) yesterday, a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).

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

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. 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, episodes of worsening function (relapses) are initially followed by recovery periods (remissions).

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