New MS Treatment Approved

New MS Treatment Approved

New MS Treatment Approved

On September 12, 2012, the Food and Drug Administration approved the drug called Aubagio which helps to treat adults with relapsing multiple sclerosis.  The drug, also called teriflunomide, is a once-a-day tablet for the treatment of the disease. 

According to Russell Katz, M.D., the director of the Division of Neurology Products under the FDA’s Center for Drug Evaluation and Research, “The relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo.”  Although the results were produced in a clinical trial, the statistics are expected to apply across a large range of patients. 

Katz states, “Multiple Sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available for patients.”

According to the FDA, Multiple Sclerosis is a “chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body.”  The disease is one of the most common neurological disabilities in young adults, and women are twice as likely as men to develop the disability.  The disease comes with worsening relapses that can cause brain lesions, and relapses can be followed by a long recovery.  Eventually, the recoveries become incomplete, and the patient’s health may decline permanently. 

The FDA states the common side effects are diarrhea, abnormal liver tests, nausea, and hair loss.  Patients with liver problems need to check with their doctor before taking this drug.  You doctor will likely conduct a blood test to check the liver function.

The FDA also reports that fetal harm can occur, so women who are pregnant should never use this drug.  A doctor will ask a female in childbearing age to show proof of a negative pregnancy test before using this drug. 

The drug is made by Bridgewater, a New Jersey based Sanofi Aventis. 

Source: Food and Drug Administration




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