Multiple Sclerosis Pill Approved by U.S. FDA

    September 14, 2012

The U.S. FDA this week approved a once-a-day pill for the treatment of multiple sclerosis (MS). The pill, being branded as “Aubagio” by Sanofi S.A., is specifically for the treatment of adults with relapsing forms of 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 Dr. Russell Katz, 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.”

According to the National Institutes of Health, MS is a chronic autoimmune disease that affects the central nervous system. It disrupts the communication between the brain and the body, causing motor skill disruption for nearly every part of the body, depending on which nerves in the brain are damaged.

As for the drug itself, side effects seen during drug trials included diarrhea, abnormal liver tests, nausea, and hair loss. Also, the box warnings for the drug warn of possible liver problems and fetal harm, including the risk of birth defects. Doctors will have to check patient’s liver function and give a pregnancy test before starting treatment with Aubagio.

“Many people living with MS struggle with the additional burden of injectable therapies administered daily to weekly,” said Dr. Aaron Miller, medical director at the center for multiple sclerosis at Mount Sinai Medical Center. “The FDA’s approval of Aubagio, a new oral treatment option, is an encouraging advancement for the MS community and may be a valuable treatment for people living with this often debilitating disease.”