Sanofi’s MS drug, Aubagio, wins FDA approval

Hannah Blake

pharmaphorum

Aubagio, a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS), has been approved by the US Food and Drug Administration (FDA). Aubagio (teriflunomide) is aimed to treat patients in the initial stages of MS, and has been developed by Bridgewater, N.J. - based Sanofi Aventis.

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’s estimated that around 2.1 million people worldwide are affected by MS, with approximately 200 new diagnoses a week in the US.

“In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo. Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.”

Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

Sanofi’s multiple sclerosis business has been building since CEO Chris Viehbacher bought US biotechnology company, Genzyme Corp., last year for US $20.1 billion. In the purchase, Sanofi gained the experimental MS medicine, Lemtrada (alemtuzumab). Genzyme submitted a Biologics License Application (sBLA) to the FDA in June 2012.